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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/NCT00022672
Registration number
NCT00022672
Ethics application status
Date submitted
10/08/2001
Date registered
27/01/2003
Date last updated
13/06/2013
Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer
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Scientific title
A Randomized, Open-label Study of the Effect of Herceptin Plus Arimidex Compared With Arimidex Alone on Progression-free Survival in Patients With HER2-positive and Hormone-receptor Positive Metastatic Breast Cancer
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Secondary ID [1]
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0
BO16216
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Universal Trial Number (UTN)
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Trial acronym
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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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0
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Condition category
Condition code
Cancer
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0
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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 - trastuzumab (Herceptin®)
Treatment: Drugs - anastrazole (Arimidex®)
Experimental: trastuzumab + anastrozole - Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
Active Comparator: anastrozole - 1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
Treatment: Drugs: trastuzumab (Herceptin®)
4mg/kg iv loading dose, followed by 2mg/kg iv weekly
Treatment: Drugs: anastrazole (Arimidex®)
1 mg tablet taken orally daily
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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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Progression Free Survival (PFS)
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Assessment method [1]
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PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm^2) an increase of 1.0 cm^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented.
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Timepoint [1]
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24 Months, End of Study (Up to 5 years)
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Secondary outcome [1]
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Percentage of Participants With Clinical Benefit
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Assessment method [1]
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Clinical Benefit was defined as stable disease for = six months or complete response or partial response.
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Timepoint [1]
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24 Months, End of Study (Up to 5 years)
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Secondary outcome [2]
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Duration of Response at 24 Months
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Assessment method [2]
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Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.
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Timepoint [2]
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24 Months
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Secondary outcome [3]
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Time to Response at 24 Months
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Assessment method [3]
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Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.
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Timepoint [3]
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24 Months
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Secondary outcome [4]
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Overall Survival at 24 Months
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Assessment method [4]
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Overall Survival is defined as the number of days from randomization to death.
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Timepoint [4]
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24 Months
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Secondary outcome [5]
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Percentage of Participants With Two-Year Survival
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Assessment method [5]
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Timepoint [5]
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24 Months
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Secondary outcome [6]
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Percentage of Participants With Overall Tumor Response at 24 Months
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Assessment method [6]
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Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response.
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Timepoint [6]
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24 Months
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Secondary outcome [7]
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Percentage of Participants With Best Tumor Response at 24 Months
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Assessment method [7]
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Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study.
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Timepoint [7]
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24 Months
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Secondary outcome [8]
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Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Final Visit Compared to Baseline
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Assessment method [8]
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Participants rated their performance status using the ECOG Questionnaire on the following scale: 0=Fully active, perform all pre-disease activities without restriction; 1=Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=Ambulatory, capable of self-care, unable to carry out any work activities, up and about more than >50% of waking hours; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled, not capable of any self-care, totally confined to bed or chair; 5=Dead.
The percentage of participants in the following categories:
Improved: Score decrease from baseline. Unchanged: Score the same as baseline. Worse: Score increase from baseline.
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Timepoint [8]
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Baseline, Final Visit (Up to 24 Months)
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Secondary outcome [9]
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Duration of Response at End of Study
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Assessment method [9]
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Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.
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Timepoint [9]
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End of Study (Up to 5 years)
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Secondary outcome [10]
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Time to Response at End of Study
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Assessment method [10]
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Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.
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Timepoint [10]
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End of Study (Up to 5 years)
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Secondary outcome [11]
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Percentage of Participants With Overall Tumor Response at End of Study
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Assessment method [11]
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Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response.
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Timepoint [11]
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End of Study (Up to 5 years)
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Secondary outcome [12]
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Percentage of Participants With Best Tumor Response at End of Study
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Assessment method [12]
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Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study.
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Timepoint [12]
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End of Study (Up to 5 years)
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Secondary outcome [13]
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Number of Participants With Adverse Events
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Assessment method [13]
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Number of participants with adverse events as a measure for safety as assessed by the collection of adverse events, laboratory tests for Hematology and Serum Chemistry, clinical assessments and cardiac monitoring.
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Timepoint [13]
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Throughout the Study (Up to 5 years)
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Eligibility
Key inclusion criteria
- postmenopausal women;
- metastatic breast cancer suitable for endocrine therapy;
- positive hormone receptor status;
- Human epidermal growth factor receptor 2 (HER2) overexpression.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- patients on hormone replacement therapy;
- previous chemotherapy for metastatic disease;
- uncontrolled cardiac disease and history of cardiac failure.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Phase
Phase 3
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2001
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2009
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Sample size
Target
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Accrual to date
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Final
208
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Box Hill
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- Darlinghurst
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- Waratah
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3128 - Box Hill
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2298 - Waratah
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Recruitment outside Australia
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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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Commercial sector/Industry
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Name [1]
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Genentech, Inc.
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Ethics approval
Ethics application status
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Summary
Brief summary
This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab
(Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line
treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2)
overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to
receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading
dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg
iv. The anticipated time on study treatment was until disease progression, and the target
sample size was 100-500 individuals.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00022672
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Trial related presentations / publications
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Contacts
Principal investigator
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Clinical Trials
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Hoffmann-La Roche
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00022672
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