A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer
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
1 other identifier
interventional
44
14 countries
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Oct 2005
Longer than P75 for phase_2 breast-cancer
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 17, 2007
CompletedFirst Posted
Study publicly available on registry
May 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
September 15, 2014
CompletedSeptember 15, 2014
September 1, 2014
6.7 years
May 17, 2007
July 15, 2014
September 9, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
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.
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
Secondary Outcomes (9)
Duration of Response - Percentage of Participants With Progressive Disease or Death
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
Duration of Response
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
Progression-free Survival (PFS) - Percentage of Participants With Progressive Disease
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
Progression-Free Survival
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
Percentage of Participants With Treatment Failure
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
- +4 more secondary outcomes
Study Arms (2)
Trastuzumab Monotherapy
ACTIVE COMPARATORParticipants 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.
Trastuzumab, Taxane
EXPERIMENTALParticipant 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- at least 10 months of Herceptin treatment for HER2-positive early breast cancer;
- metastatic breast cancer \>=12 months after discontinuation of Herceptin;
- measurable disease.
You may not qualify if:
- previous chemotherapy for metastatic breast cancer;
- brain metastases;
- invasive malignancy other than metastatic breast cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
Unknown Facility
Geelong, Victoria, 3220, Australia
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Klagenfurt, 9026, Austria
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Salzburg, 5020, Austria
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Vienna, 1090, Austria
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Vöcklabruck, 4840, Austria
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Brussels, 1090, Belgium
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Namur, 5000, Belgium
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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
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Winnipeg, Manitoba, R2H 2A6, Canada
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Brampton, Ontario, L6R 3J7, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Beijing, 100021, China
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Guangzhou, 510060, China
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Shanghai, 200032, China
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Wuhan, 430030, China
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Berlin, 12203, Germany
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Cologne, 50931, Germany
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Düsseldorf, 40225, Germany
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Hamburg, 20246, Germany
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Krefeld, 47805, Germany
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Lemgo, 32657, Germany
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München, 81675, Germany
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Tübingen, 72076, Germany
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Budapest, 1031, Hungary
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Budapest, 1083, Hungary
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Budapest, 1122, Hungary
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Budapest, 1145, Hungary
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Kecskemét, 6000, Hungary
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Szeged, 6701, Hungary
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Chieti, 66100, Italy
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Genova, 16132, Italy
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Roma, 00168, Italy
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San Giovanni Rotondo, 71013, Italy
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Sassari, 07100, Italy
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Mérida, 97500, Mexico
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Panama City, 83-0669, Panama
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Gdansk, 80-214, Poland
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Gliwice, 44-101, Poland
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Lodz, 94-306, Poland
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Kazan', 420029, Russia
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Moscow, 115478, Russia
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Saint Petersburg, 197758, Russia
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Barcelona, Barcelona, 08035, Spain
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Barcelona, Barcelona, 08036, Spain
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Jaén, Jaen, 23007, Spain
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A Coruña, La Coruña, 15009, Spain
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Madrid, Madrid, 28041, Spain
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Valencia, Valencia, 46009, Spain
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Valencia, Valencia, 46010, Spain
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Zaragoza, Zaragoza, 50009, Spain
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Changhua, 500, Taiwan
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Taipei, 00112, Taiwan
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Taipei, 100, Taiwan
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Taipei, Taiwan
Unknown Facility
Taoyuan District, 333, Taiwan
Related Publications (1)
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.
PMID: 24051172DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2007
First Posted
May 21, 2007
Study Start
October 1, 2005
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
September 15, 2014
Results First Posted
September 15, 2014
Record last verified: 2014-09