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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00475670
Registration number
NCT00475670
Ethics application status
Date submitted
17/05/2007
Date registered
21/05/2007
Date last updated
15/09/2014
Titles & IDs
Public title
A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer
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Scientific title
An Open-label Study of the Effect of First-line Herceptin Alone or in Combination With a Taxane on Tumor Response and Disease Progression in Patients With Metastatic Breast Cancer Who Relapsed After Receiving Adjuvant Herceptin for HER2-positive Early Breast Cancer
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Secondary ID [1]
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WO17299
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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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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 - Trastuzumab
Treatment: Drugs - Taxane (docetaxel or paclitaxel)
Active comparator: Trastuzumab Monotherapy - Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenous (i.v.) on Day 1, followed by 2mg/kg i.v. weekly, or an initial loading dose of 8 mg/kg i.v. loading dose on Day 1, followed by 6 mg/kg i.v. every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
Experimental: Trastuzumab, Taxane - Participant received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by 2mg/kg i.v. weekly, or an initial loading dose of 8 mg/kg i.v. loading dose, followed by 6 mg/kg i.v. every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death; and concomitant taxane, which is either 100 milligrams per square meter (mg/m2) docetaxel i.v. every 3 weeks, or 75 mg/m2 weekly or 175 mg/m2 every 3 weeks paclitaxel for at least 18 weeks, or more at the discretion of the investigator.
Treatment: Drugs: Trastuzumab
4 mg/kg i.v. loading dose on Day 1, followed by 2 mg/kg i.v. weekly; or 8 mg/kg i.v. loading dose, followed by 6 mg/kg i.v. every 3 weeks until disease progression, unacceptable toxicity, withdrawal or death.
Treatment: Drugs: Taxane (docetaxel or paclitaxel)
Docetaxel 100 mg/m2 i.v. every 3 weeks, or paclitaxel administered in a dose of 75 mg/m2 i.v. weekly or 175 mg/m2 i.v. every 3 weeks for at least 18 weeks, or more at the discretion of the investigator. Choice of taxane at the discretion of the investigator. Taxane may be administered at the same time, or 24 hours after, administration of trastuzumab.
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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 Achieving Complete Response (CR) or Partial Response (PR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Guidelines
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Assessment method [1]
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CR was defined for target lesions (TLs) as the disappearance of all lesions, and for nontarget lesions (NTLs) as the disappearance of all nontarget nonmeasurable lesions. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs. 95% confidence interval for one-sample binomial using Pearson-Clopper method.
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Timepoint [1]
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Baseline (BL); Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited
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Secondary outcome [1]
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Duration of Response - Percentage of Participants With Progressive Disease or Death
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Assessment method [1]
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Duration of response was defined as the time from first confirmed CR or PR until death or progressive disease (PD). For TLs, PD was defined as at least a 20% increase in the SLD of the TL, taking as reference the smallest SLD recorded since the beginning of treatment or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of one or more new lesions or unequivocal progression of existing non target non-measurable lesions. Participants were censored at the date of the last tumor assessment.
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Timepoint [1]
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BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited
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Secondary outcome [2]
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Duration of Response
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Assessment method [2]
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The time, in months, from when the response (CR or PR) was first noted until the date of documented PD, death, or withdrawal, whichever occurred first. Participants were censored at the date of the last tumor assessment.
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Timepoint [2]
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BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited
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Secondary outcome [3]
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Progression-free Survival (PFS) - Percentage of Participants With Progressive Disease
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Assessment method [3]
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PFS was defined as the time from day of first study drug infusion until death or PD. Participants were censored at the date of the last tumor assessment.
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Timepoint [3]
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BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited
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Secondary outcome [4]
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Progression-Free Survival
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Assessment method [4]
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The time, in months, from BL to PFS event.
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Timepoint [4]
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BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited
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Secondary outcome [5]
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Percentage of Participants With Treatment Failure
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Assessment method [5]
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Treatment failure was defined as the time from first study drug infusion to failure. Failure was defined as any of the following: PD, death, withdrawal due to adverse event (AE) or lab abnormality, or refusal of treatment. Participants were censored at the last date recorded in the case report form (CRF) or the date of withdrawal.
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Timepoint [5]
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BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited
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Secondary outcome [6]
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Time to Treatment Failure
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Assessment method [6]
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The time, in months, from BL to treatment failure.
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Timepoint [6]
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BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited
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Secondary outcome [7]
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Percentage of Participants With Clinical Benefit According to RECIST Guidelines
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Assessment method [7]
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Clinical benefit was defined as stable disease (SD) for 6 months or longer, or a confirmed overall response of CR or PR. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the beginning of treatment. For NTLs, SD was synonymous with incomplete response and defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits.
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Timepoint [7]
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BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited
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Secondary outcome [8]
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Overall Survival - Percentage of Participants Who Died
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Assessment method [8]
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OS was defined as the time from the date of enrollment to the date of death due to any cause. Participants were censored at the last date recorded in the CRF.
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Timepoint [8]
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BL, Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 25, 37, and 5 at the last administration of study treatment, every 24 weeks thereafter until disease progression or death, yearly thereafter up to 2 years after cessation of recruitment
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Secondary outcome [9]
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Overall Survival
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Assessment method [9]
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The time, in months, from BL to death due to any cause.
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Timepoint [9]
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BL, Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 25, 37, and 52 at the last administration of study treatment, every 24 weeks thereafter until disease progression or death, yearly thereafter up to 2 years after cessation of recruitment
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Eligibility
Key inclusion criteria
* at least 10 months of Herceptin treatment for HER2-positive early breast cancer;
* metastatic breast cancer >=12 months after discontinuation of Herceptin;
* measurable disease.
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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
* previous chemotherapy for metastatic breast cancer;
* brain metastases;
* invasive malignancy other than metastatic breast cancer.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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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
1/10/2005
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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
1/06/2012
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Sample size
Target
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Accrual to date
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Final
44
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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- Geelong
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Recruitment postcode(s) [1]
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3220 - Geelong
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Recruitment outside Australia
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Austria
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Klagenfurt
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Austria
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Salzburg
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Austria
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Vöcklabruck
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Austria
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Wien
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Belgium
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Brussel
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Belgium
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Namur
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Brazil
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RS
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Guangzhou
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China
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Shanghai
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China
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Wuhan
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Germany
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Berlin
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Germany
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Düsseldorf
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Germany
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Hamburg
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Germany
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Krefeld
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Germany
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Köln
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Germany
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Lemgo
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München
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Germany
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Tübingen
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Hungary
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Hungary
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Kecskemet
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Hungary
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Szeged
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Italy
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Chieti
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Italy
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Genova
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Italy
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Roma
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Italy
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San Giovanni Rotondo
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Italy
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Sassari
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Mexico
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Merida
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Gdansk
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Gliwice
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Lodz
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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La Coruña
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Spain
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Barcelona
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Spain
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Jaen
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Spain
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Madrid
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Spain
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Valencia
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Zaragoza
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Changhua
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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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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Ethics approval
Ethics application status
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Summary
Brief summary
This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without a taxane for the first line treatment of metastatic breast cancer in women who have relapsed at least 12 months after a minimum of 10 months of (neo)adjuvant treatment with Herceptin for HER2-positive early breast cancer.Patients will receive either Herceptin monotherapy (loading dose of 4mg/kg iv, followed by weekly doses of 2mg/kg iv, or 8mg/kg loading dose followed by 3-weekly doses of 6mg/kg)or Herceptin + a taxane (docetaxel 100mg/m2 iv every 3 weeks, or paclitaxel 175mg/m2 iv every 3 weeks or 75mg/m2 every week). The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.
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Trial website
https://clinicaltrials.gov/study/NCT00475670
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Trial related presentations / publications
Lang I, Bell R, Feng FY, Lopez RI, Jassem J, Semiglazov V, Al-Sakaff N, Heinzmann D, Chang J. Trastuzumab retreatment after relapse on adjuvant trastuzumab therapy for human epidermal growth factor receptor 2-positive breast cancer: final results of the Retreatment after HErceptin Adjuvant trial. Clin Oncol (R Coll Radiol). 2014 Feb;26(2):81-9. doi: 10.1016/j.clon.2013.08.011. Epub 2013 Sep 17.
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Public notes
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Contacts
Principal investigator
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Address
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Hoffmann-La Roche
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00475670
Download to PDF