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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00045032
Registration number
NCT00045032
Ethics application status
Date submitted
6/09/2002
Date registered
27/01/2003
Date last updated
27/04/2017
Titles & IDs
Public title
Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer
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Scientific title
A Randomized Three-Arm, Multicenter Comparison of 1 Year and 2 Years of Herceptin Versus No Herceptin in Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy
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Secondary ID [1]
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BIG-01-01
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Secondary ID [2]
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BO16348
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Universal Trial Number (UTN)
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Trial acronym
HERA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Herceptin
Treatment: Drugs - Herceptin
No Intervention: Observation Arm - Participants who have completed definitive surgery and systemic adjuvant chemotherapy will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin will be provided.
Experimental: Herceptin 1-Year Arm - Participants who have completed definitive surgery and systemic adjuvant chemotherapy will receive Herceptin for 1 year or until disease recurrence, whichever occurs first. Participants will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
Experimental: Herceptin 2-Year Arm - Participants who have completed definitive surgery and systemic adjuvant chemotherapy will receive Herceptin for 2 years or until disease recurrence, whichever occurs first. Participants will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
Treatment: Drugs: Herceptin
Herceptin will be given as a loading dose of 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.
Treatment: Drugs: Herceptin
Herceptin will be given as a loading dose of 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up
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Assessment method [1]
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DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an Independent Data Monitoring Committee (IDMC) in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.
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Timepoint [1]
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From Baseline until time of event (median of 1 year)
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Primary outcome [2]
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Percentage of Participants With DFS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up
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Assessment method [2]
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0
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.
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Timepoint [2]
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From Baseline until time of event (median of 1 year)
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Primary outcome [3]
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DFS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up
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Assessment method [3]
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DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95 percent (%) confidence interval (CI) were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.
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Timepoint [3]
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Year 2
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Primary outcome [4]
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DFS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up
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Assessment method [4]
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DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.
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Timepoint [4]
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Year 2
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Primary outcome [5]
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Percentage of Participants With DFS Events Compared to Observation: 8-Year Median Follow-Up
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Assessment method [5]
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DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.
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Timepoint [5]
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From Baseline until time of event (median of 8 years)
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Primary outcome [6]
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DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
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Assessment method [6]
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DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
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Timepoint [6]
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Year 3
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Primary outcome [7]
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DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
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Assessment method [7]
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DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
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Timepoint [7]
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Year 5
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Primary outcome [8]
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DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
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Assessment method [8]
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DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
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Timepoint [8]
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Year 7
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Primary outcome [9]
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DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
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Assessment method [9]
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0
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
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Timepoint [9]
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Year 8
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Primary outcome [10]
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Percentage of Participants With DFS Events Compared to Observation: 10-Year Maximum Follow-Up
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Assessment method [10]
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0
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.
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Timepoint [10]
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From Baseline until time of event (maximum of 10 years)
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Primary outcome [11]
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0
DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
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Assessment method [11]
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0
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.
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Timepoint [11]
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0
Year 3
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Primary outcome [12]
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0
DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
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Assessment method [12]
0
0
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.
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Timepoint [12]
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0
Year 5
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Primary outcome [13]
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0
DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
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Assessment method [13]
0
0
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.
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Timepoint [13]
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0
Year 7
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Primary outcome [14]
0
0
DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
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Assessment method [14]
0
0
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.
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Timepoint [14]
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Year 8
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Primary outcome [15]
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DFS Rate at Year 9 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
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Assessment method [15]
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DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.
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Timepoint [15]
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Year 9
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Primary outcome [16]
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DFS Rate at Year 10 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
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Assessment method [16]
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DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.
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Timepoint [16]
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Year 10
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Secondary outcome [1]
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Percentage of Participants With DFS Events in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up
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Assessment method [1]
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0
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.
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Timepoint [1]
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0
From Baseline until time of event (maximum of 10 years)
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Secondary outcome [2]
0
0
DFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up
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Assessment method [2]
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0
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.
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Timepoint [2]
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0
Years 3, 5, 7, 8, 9, 10
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Secondary outcome [3]
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Percentage of Participants With Overall Survival (OS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up
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Assessment method [3]
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OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.
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Timepoint [3]
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0
From Baseline until time of event (median of 1 year)
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Secondary outcome [4]
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0
Percentage of Participants With OS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up
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Assessment method [4]
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0
OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.
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Timepoint [4]
0
0
From Baseline until time of event (median of 1 year)
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Secondary outcome [5]
0
0
OS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up
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Assessment method [5]
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0
OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.
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Timepoint [5]
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Year 2
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Secondary outcome [6]
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0
OS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up
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Assessment method [6]
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0
OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.
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Timepoint [6]
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0
Year 2
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Secondary outcome [7]
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Percentage of Participants With OS Events Compared to Observation: 8-Year Median Follow-Up
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Assessment method [7]
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0
OS events referred to death from any cause. The percentage of participants who died was reported.
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Timepoint [7]
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0
From Baseline until time of event (median of 8 years)
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Secondary outcome [8]
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0
OS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
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Assessment method [8]
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0
OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
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Timepoint [8]
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0
Years 3, 5, 7, 8
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Secondary outcome [9]
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Percentage of Participants With OS Events Compared to Observation: 11-Year Median Follow-Up
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Assessment method [9]
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0
OS events referred to death from any cause. The percentage of participants who died was reported.
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Timepoint [9]
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0
From Baseline until time of event (median of 11 years)
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Secondary outcome [10]
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0
OS Rate According to Kaplan-Meier Analysis Compared to Observation: 11-Year Median Follow-Up
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Assessment method [10]
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0
OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.
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Timepoint [10]
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0
Years 3, 5, 7, 9, 10, 11, 12
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Secondary outcome [11]
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0
Percentage of Participants With OS Events in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up
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Assessment method [11]
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0
OS events referred to death from any cause. The percentage of participants who died was reported.
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Timepoint [11]
0
0
From Baseline until time of event (median of 11 years)
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Secondary outcome [12]
0
0
OS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up
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Assessment method [12]
0
0
OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.
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Timepoint [12]
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0
Years 3, 5, 7, 9, 10, 11, 12
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Secondary outcome [13]
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0
Percentage of Participants With Recurrence-Free Survival (RFS) Events Compared to Observation: 8-Year Median Follow-Up
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Assessment method [13]
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0
RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported.
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Timepoint [13]
0
0
From Baseline until time of event (median of 8 years)
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Secondary outcome [14]
0
0
RFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
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Assessment method [14]
0
0
RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
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Timepoint [14]
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0
Years 3, 5, 7, 8
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Secondary outcome [15]
0
0
Percentage of Participants With RFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
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Assessment method [15]
0
0
RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported.
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Timepoint [15]
0
0
From Baseline until time of event (median of 8 years)
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Secondary outcome [16]
0
0
RFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
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Assessment method [16]
0
0
RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
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Timepoint [16]
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0
Years 3, 5, 7, 8
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Secondary outcome [17]
0
0
Percentage of Participants With Distant Disease-Free Survival (DDFS) Events Compared to Observation: 8-Year Median Follow-Up
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Assessment method [17]
0
0
DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported.
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Timepoint [17]
0
0
From Baseline until time of event (median of 8 years)
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Secondary outcome [18]
0
0
DDFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
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Assessment method [18]
0
0
DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
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Timepoint [18]
0
0
Years 3, 5, 7, 8
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Secondary outcome [19]
0
0
Percentage of Participants With DDFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
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Assessment method [19]
0
0
DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported.
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Timepoint [19]
0
0
From Baseline until time of event (median of 8 years)
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Secondary outcome [20]
0
0
DDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
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Assessment method [20]
0
0
DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
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Timepoint [20]
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0
Years 3, 5, 7, 8
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Secondary outcome [21]
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0
Percentage of Participants With Tumor Recurrence (TR) Compared to Observation: 8-Year Median Follow-Up
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Assessment method [21]
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0
The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.
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Timepoint [21]
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0
From Baseline until time of event (median of 8 years)
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Secondary outcome [22]
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0
TR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
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Assessment method [22]
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0
The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.
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Timepoint [22]
0
0
Years 3, 5, 7, 8
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Secondary outcome [23]
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0
Percentage of Participants With TR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
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Assessment method [23]
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0
The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.
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Timepoint [23]
0
0
From Baseline until time of event (median of 8 years)
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Secondary outcome [24]
0
0
TR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
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Assessment method [24]
0
0
The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.
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Timepoint [24]
0
0
Years 3, 5, 7, 8
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Secondary outcome [25]
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0
Percentage of Participants With Distant Tumor Recurrence (DTR) Compared to Observation: 8-Year Median Follow-Up
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Assessment method [25]
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0
The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.
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Timepoint [25]
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0
From Baseline until time of event (median of 8 years)
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Secondary outcome [26]
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0
DTR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
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Assessment method [26]
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0
The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.
Query!
Timepoint [26]
0
0
Years 3, 5, 7, 8
Query!
Secondary outcome [27]
0
0
Percentage of Participants With DTR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
Query!
Assessment method [27]
0
0
The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.
Query!
Timepoint [27]
0
0
From Baseline until time of event (median of 8 years)
Query!
Secondary outcome [28]
0
0
DTR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
Query!
Assessment method [28]
0
0
The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.
Query!
Timepoint [28]
0
0
Years 3, 5, 7, 8
Query!
Secondary outcome [29]
0
0
Percentage of Participants With Restricted Disease-Free Survival (RDFS) Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
Query!
Assessment method [29]
0
0
RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants with at least one RDFS event was reported.
Query!
Timepoint [29]
0
0
From Baseline until time of event (median of 8 years)
Query!
Secondary outcome [30]
0
0
RDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
Query!
Assessment method [30]
0
0
RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants free of RDFS events (i.e., the RDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
Query!
Timepoint [30]
0
0
Years 3, 5, 7, 8
Query!
Secondary outcome [31]
0
0
Percentage of Participants With Primary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up
Query!
Assessment method [31]
0
0
Primary cardiac endpoint events included the occurrence of any of the following between randomization and new therapy for recurrent disease: symptomatic New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF) confirmed by a cardiologist with a drop in left ventricular ejection fraction (LVEF) at least 10 percentage points from Baseline and to a value less than (<) 50%, and documentation of definite or probable cardiac death. Definite cardiac death included CHF, myocardial infarction, or primary arrhythmia. Probable cardiac death included unexpected sudden death within 24 hours of a cardiac event (syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology. The percentage of participants with at least one primary cardiac endpoint event was reported. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial.
Query!
Timepoint [31]
0
0
From Baseline until time of event (maximum up to 10 years)
Query!
Secondary outcome [32]
0
0
Percentage of Participants With Secondary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up
Query!
Assessment method [32]
0
0
Secondary cardiac endpoint events included NYHA Class I or II CHF with a drop in LVEF measured by multiple-gated acquisition or electrocardiogram, unless the subsequent assessment of LVEF indicated a return to levels that did not meet the definition of a significant LVEF drop. A significant LVEF drop was defined as an absolute reduction of at least 10 percentage points from Baseline and to a value <50%. The percentage of participants with at least one secondary cardiac endpoint event was reported, excluding those with both a primary and secondary cardiac endpoint event. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial.
Query!
Timepoint [32]
0
0
From Baseline until time of event (maximum up to 10 years)
Query!
Eligibility
Key inclusion criteria
- Non-metastatic primary invasive breast cancer overexpressing HER2 (determined by
immunohistochemistry 3+ or positive fluorescence in situ hybridization test) that has
been histologically confirmed, adequately excised, axillary node positive or negative,
and tumor size at least T1c according to Tumor/Node/Metastasis (TNM) staging
- Completion of at least 4 cycles of (neo-)adjuvant systemic chemotherapy, definitive
surgery, and radiotherapy, if applicable
- Known hormone receptor status
- Baseline left ventricular ejection fraction (LVEF) greater than or equal to (=) 55
percent (%)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Prior invasive breast carcinoma
- Other malignancies except for curatively treated basal and squamous cell carcinoma of
the skin or in situ carcinoma of the cervix
- Clinical T4 tumors
- Cumulative doxorubicin exposure greater than (>) 360 milligrams per meter-squared
(mg/m^2) or epirubicin >720 mg/m^2 or any prior anthracyclines unrelated to the
present breast cancer
- Peripheral stem cell or bone marrow stem cell support
- Prior mediastinal irradiation except for internal mammary node irradiation for the
present breast cancer
- Non-irradiated internal mammary nodes or supraclavicular lymph node involvement
- Prior anti-HER2 therapy for any other reason or other prior biologic or immunotherapy
for breast cancer
- Concurrent anti-cancer treatment in another investigational trial
- Serious cardiac or pulmonary conditions/illness, or any other conditions that could
interfere with planned treatment
- Poor hematologic, hepatic, or renal function
- Pregnancy or lactation
- Women of childbearing potential or less than 1 year post-menopause unwilling to use
adequate contraceptive measures
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/2001
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/06/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
5099
Query!
Recruitment in Australia
Recruitment state(s)
ACT,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Saint John of God Hospital - Geelong
Query!
Recruitment hospital [2]
0
0
Toowoomba Hospital - Toowoomba
Query!
Recruitment hospital [3]
0
0
Andrew Love Cancer Centre - Geelong
Query!
Recruitment hospital [4]
0
0
Mount Hospital - Perth
Query!
Recruitment postcode(s) [1]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [2]
0
0
4350 - Toowoomba
Query!
Recruitment postcode(s) [3]
0
0
6000 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
Argentina
Query!
State/province [1]
0
0
Buenos Aires
Query!
Country [2]
0
0
Austria
Query!
State/province [2]
0
0
Feldkirch-Tisis
Query!
Country [3]
0
0
Austria
Query!
State/province [3]
0
0
Innsbruck
Query!
Country [4]
0
0
Austria
Query!
State/province [4]
0
0
Klagenfurt
Query!
Country [5]
0
0
Austria
Query!
State/province [5]
0
0
Linz Donau
Query!
Country [6]
0
0
Austria
Query!
State/province [6]
0
0
Salzburg
Query!
Country [7]
0
0
Austria
Query!
State/province [7]
0
0
St. Poelten
Query!
Country [8]
0
0
Austria
Query!
State/province [8]
0
0
Vienna
Query!
Country [9]
0
0
Austria
Query!
State/province [9]
0
0
Villach
Query!
Country [10]
0
0
Austria
Query!
State/province [10]
0
0
Voecklabruck
Query!
Country [11]
0
0
Austria
Query!
State/province [11]
0
0
Wiener Neustadt
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Antwerp
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Baudour
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Brussels
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Charleroi
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Kortrijk
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
La Louviere
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Leuven
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Liege
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Namur
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Oostende
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Verviers
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
Rio Grande do Sul
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
Porto Alegre
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
Rio de Janeiro
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Santo Andre
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Alberta
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
British Columbia
Query!
Country [29]
0
0
Canada
Query!
State/province [29]
0
0
Manitoba
Query!
Country [30]
0
0
Canada
Query!
State/province [30]
0
0
Ontario
Query!
Country [31]
0
0
Canada
Query!
State/province [31]
0
0
Prince Edward Island
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
Quebec
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Saskatchewan
Query!
Country [34]
0
0
Chile
Query!
State/province [34]
0
0
Santiago
Query!
Country [35]
0
0
China
Query!
State/province [35]
0
0
Hong Kong
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Wuhan
Query!
Country [37]
0
0
Colombia
Query!
State/province [37]
0
0
Bogota
Query!
Country [38]
0
0
Croatia
Query!
State/province [38]
0
0
Split
Query!
Country [39]
0
0
Denmark
Query!
State/province [39]
0
0
Esbjerg
Query!
Country [40]
0
0
Denmark
Query!
State/province [40]
0
0
Herning
Query!
Country [41]
0
0
Denmark
Query!
State/province [41]
0
0
Hillerod
Query!
Country [42]
0
0
Denmark
Query!
State/province [42]
0
0
Naestved
Query!
Country [43]
0
0
Denmark
Query!
State/province [43]
0
0
Sonderborg
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Caen
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Limoges
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Metz
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Berlin
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Essen
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Freiburg
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Halle
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Hanover
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Heidelberg
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Karlsruhe
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Kiel
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Leonberg
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Magdeburg
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Munich
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Rostock
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Ulm
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Wiesbaden
Query!
Country [61]
0
0
Greece
Query!
State/province [61]
0
0
Crete
Query!
Country [62]
0
0
Greece
Query!
State/province [62]
0
0
Athens
Query!
Country [63]
0
0
Guatemala
Query!
State/province [63]
0
0
Guatemala City
Query!
Country [64]
0
0
Hong Kong
Query!
State/province [64]
0
0
Shatin, New Territories
Query!
Country [65]
0
0
Hungary
Query!
State/province [65]
0
0
Budapest
Query!
Country [66]
0
0
Ireland
Query!
State/province [66]
0
0
Cork
Query!
Country [67]
0
0
Israel
Query!
State/province [67]
0
0
Safed
Query!
Country [68]
0
0
Italy
Query!
State/province [68]
0
0
Alba
Query!
Country [69]
0
0
Italy
Query!
State/province [69]
0
0
Alzano-Lombardo
Query!
Country [70]
0
0
Italy
Query!
State/province [70]
0
0
Aviano
Query!
Country [71]
0
0
Italy
Query!
State/province [71]
0
0
Bergamo
Query!
Country [72]
0
0
Italy
Query!
State/province [72]
0
0
Biella
Query!
Country [73]
0
0
Italy
Query!
State/province [73]
0
0
Bologna
Query!
Country [74]
0
0
Italy
Query!
State/province [74]
0
0
Brescia
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Cagliari
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Carpi
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Como
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Cuneo
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Firenze (Florence)
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
Florence
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Forli
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Genoa
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Lecco
Query!
Country [84]
0
0
Italy
Query!
State/province [84]
0
0
Livorno
Query!
Country [85]
0
0
Italy
Query!
State/province [85]
0
0
Mantova
Query!
Country [86]
0
0
Italy
Query!
State/province [86]
0
0
Milan
Query!
Country [87]
0
0
Italy
Query!
State/province [87]
0
0
Modena
Query!
Country [88]
0
0
Italy
Query!
State/province [88]
0
0
Parma
Query!
Country [89]
0
0
Italy
Query!
State/province [89]
0
0
Pavia
Query!
Country [90]
0
0
Italy
Query!
State/province [90]
0
0
Perugia
Query!
Country [91]
0
0
Italy
Query!
State/province [91]
0
0
Reggio Emilia
Query!
Country [92]
0
0
Italy
Query!
State/province [92]
0
0
Rome
Query!
Country [93]
0
0
Italy
Query!
State/province [93]
0
0
Rozzano
Query!
Country [94]
0
0
Italy
Query!
State/province [94]
0
0
Sassari
Query!
Country [95]
0
0
Italy
Query!
State/province [95]
0
0
Trento
Query!
Country [96]
0
0
Italy
Query!
State/province [96]
0
0
Turin
Query!
Country [97]
0
0
Japan
Query!
State/province [97]
0
0
Kanagawa
Query!
Country [98]
0
0
Japan
Query!
State/province [98]
0
0
Tokyo
Query!
Country [99]
0
0
Korea, Republic of
Query!
State/province [99]
0
0
Seoul
Query!
Country [100]
0
0
Netherlands
Query!
State/province [100]
0
0
Maastricht
Query!
Country [101]
0
0
Netherlands
Query!
State/province [101]
0
0
Sittard
Query!
Country [102]
0
0
Netherlands
Query!
State/province [102]
0
0
Utrecht
Query!
Country [103]
0
0
Poland
Query!
State/province [103]
0
0
Gdansk
Query!
Country [104]
0
0
Poland
Query!
State/province [104]
0
0
Gliwice
Query!
Country [105]
0
0
Poland
Query!
State/province [105]
0
0
Poznan
Query!
Country [106]
0
0
Poland
Query!
State/province [106]
0
0
Warsaw
Query!
Country [107]
0
0
Portugal
Query!
State/province [107]
0
0
Coimbra
Query!
Country [108]
0
0
Portugal
Query!
State/province [108]
0
0
Faro
Query!
Country [109]
0
0
Portugal
Query!
State/province [109]
0
0
Lisboa
Query!
Country [110]
0
0
Portugal
Query!
State/province [110]
0
0
Lisbon
Query!
Country [111]
0
0
Russian Federation
Query!
State/province [111]
0
0
Moscow
Query!
Country [112]
0
0
Singapore
Query!
State/province [112]
0
0
Singapore
Query!
Country [113]
0
0
South Africa
Query!
State/province [113]
0
0
Cape Town
Query!
Country [114]
0
0
South Africa
Query!
State/province [114]
0
0
Durban
Query!
Country [115]
0
0
South Africa
Query!
State/province [115]
0
0
Johannesburg
Query!
Country [116]
0
0
South Africa
Query!
State/province [116]
0
0
Lynnwood
Query!
Country [117]
0
0
Spain
Query!
State/province [117]
0
0
Alzira
Query!
Country [118]
0
0
Spain
Query!
State/province [118]
0
0
Barcelona
Query!
Country [119]
0
0
Spain
Query!
State/province [119]
0
0
Granada
Query!
Country [120]
0
0
Spain
Query!
State/province [120]
0
0
Guadalajara
Query!
Country [121]
0
0
Spain
Query!
State/province [121]
0
0
Huelva
Query!
Country [122]
0
0
Spain
Query!
State/province [122]
0
0
Jaen
Query!
Country [123]
0
0
Spain
Query!
State/province [123]
0
0
La Coruna
Query!
Country [124]
0
0
Spain
Query!
State/province [124]
0
0
La Laguna
Query!
Country [125]
0
0
Spain
Query!
State/province [125]
0
0
Las Palmas de Gran Canaria
Query!
Country [126]
0
0
Spain
Query!
State/province [126]
0
0
Las Palmas
Query!
Country [127]
0
0
Spain
Query!
State/province [127]
0
0
Madrid
Query!
Country [128]
0
0
Spain
Query!
State/province [128]
0
0
Orense
Query!
Country [129]
0
0
Spain
Query!
State/province [129]
0
0
Pontevedra
Query!
Country [130]
0
0
Spain
Query!
State/province [130]
0
0
Sabadell
Query!
Country [131]
0
0
Spain
Query!
State/province [131]
0
0
Santa Cruz de Tenerife
Query!
Country [132]
0
0
Spain
Query!
State/province [132]
0
0
Sevilla
Query!
Country [133]
0
0
Spain
Query!
State/province [133]
0
0
Toledo
Query!
Country [134]
0
0
Spain
Query!
State/province [134]
0
0
Valencia
Query!
Country [135]
0
0
Spain
Query!
State/province [135]
0
0
Vigo Pontevedra
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Spain
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Zaragoza
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Sweden
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Linkoping
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Sweden
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Malmo
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Sweden
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Molndal
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Sweden
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Stockholm
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Sweden
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Umea
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Sweden
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Uppsala
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Switzerland
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Aarau
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Chur
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Switzerland
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Lausanne
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Switzerland
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Mendrisio
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Switzerland
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St. Gallen
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Switzerland
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Zurich
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Thailand
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Bangkok
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United Kingdom
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England
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Breast International Group
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Other
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European Organisation for Research and Treatment of Cancer - EORTC
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Other
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NCIC Clinical Trials Group
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Other
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ETOP IBCSG Partners Foundation
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Ethics approval
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Summary
Brief summary
The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus
observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have
completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if
applicable. Efficacy and safety will be assessed for 10 years from randomization for each
participant. All participants will continue to be followed for survival until 10 years after
enrollment of the last participant.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00045032
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Trial related presentations / publications
Jahanzeb M. Adjuvant trastuzumab therapy for HER2-positive breast cancer. Clin Breast Cancer. 2008 Aug;8(4):324-33. doi: 10.3816/CBC.2008.n.037.
Shiroiwa T, Fukuda T, Shimozuma K, Ohashi Y, Tsutani K. The model-based cost-effectiveness analysis of 1-year adjuvant trastuzumab treatment: based on 2-year follow-up HERA trial data. Breast Cancer Res Treat. 2008 Jun;109(3):559-66. doi: 10.1007/s10549-007-9679-4. Epub 2007 Jul 28.
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Public notes
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Contacts
Principal investigator
Name
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Martine J. Piccart-Gebhart, MD, PhD
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Jules Bordet Institute
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00045032
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