A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer
An Open-Label, Randomized Phase II Study of Herceptin (Trastuzumab), Taxotere (Docetaxel), and Xeloda (Capecitabine) in Combination, Versus Herceptin (Trastuzumab) Plus Taxotere (Docetaxel), in Patients With Advanced and/or Metastatic Breast Cancers That Overexpress HER2
1 other identifier
interventional
225
15 countries
51
Brief Summary
This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin) and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with previously untreated HER2-positive advanced and/or metastatic breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Feb 2002
Typical duration for phase_2 breast-cancer
51 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
February 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 20, 2016
CompletedFirst Posted
Study publicly available on registry
April 22, 2016
CompletedResults Posted
Study results publicly available
November 22, 2016
CompletedNovember 22, 2016
September 1, 2016
4.1 years
April 20, 2016
June 15, 2016
September 30, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)
Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a best overall response for CR or PR was reported. The exact 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper method.
Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Secondary Outcomes (5)
Percentage of Participants With Death or Disease Progression According to RECIST
Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Progression-Free Survival (PFS) According to RECIST
Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Percentage of Participants Who Died
Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)
Overall Survival (OS)
Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)
Duration of Response (DOR) According to RECIST
Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Study Arms (2)
Herceptin + Taxotere
EXPERIMENTALParticipants will receive dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal.
Herceptin + Taxotere + Xeloda
EXPERIMENTALParticipants will receive triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal.
Interventions
Participants will receive oral Xeloda, 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle.
Participants will receive Taxotere, 75 milligrams per meter-squared (mg/m\^2) in the Herceptin + Taxotere + Xeloda arm or 100 mg/m\^2 in the Herceptin + Taxotere arm, via IV infusion on Day 1 of each 21-day cycle. The lower starting dose will be used in the triple-therapy arm.
Participants will receive Herceptin, 6 milligrams per kilogram (mg/kg) via IV infusion, on Day 1 of each 21-day cycle. The first dose will be a loading dose of 8 mg/kg in Cycle 1; the dose of 6 mg/kg will be given from Cycle 2 onward.
Eligibility Criteria
You may qualify if:
- Histologically confirmed, HER2-positive advanced and/or metastatic breast cancer not amenable to curative therapy
- At least one measurable lesion according to RECIST
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Baseline left ventricular ejection fraction (LVEF) at least 50%
You may not qualify if:
- Pregnant, lactating, or women of childbearing potential who are not surgically sterile or not willing to use adequate contraceptive methods
- Previous treatment with Herceptin or other anti-HER therapies, or any previous chemotherapy for advanced or metastatic disease
- Past medical history significant for any cardiac or central nervous system (CNS) disorders
- Poor hematologic, renal, or hepatic function
- Chronic corticosteroid therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Unknown Facility
Adelaide, 5011, Australia
Unknown Facility
Brisbane, 4066, Australia
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Camperdown, 2050, Australia
Unknown Facility
Geelong, 3220, Australia
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Melbourne, 3002, Australia
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Melbourne, 3181, Australia
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Perth, 6000, Australia
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Southport, 4215, Australia
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Porto Alegre, 91350-200, Brazil
Unknown Facility
Rio de Janeiro, 20560-120, Brazil
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São Paulo, 01401-901, Brazil
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Calgary, Alberta, T2N 4N2, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Québec, Quebec, G1S 4L8, Canada
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San José, 10103, Costa Rica
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Turku, 20520, Finland
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Besançon, 25030, France
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Grenoble, 38000, France
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Marseille, 13273, France
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Paris, 75231, France
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Pierre-Bénite, 69310, France
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Rennes, 35042, France
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Athens, 11526, Greece
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Heraklion, 71110, Greece
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Pátrai, 26500, Greece
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Guatemala City, 01010, Guatemala
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Legnago, 37045, Italy
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Noale, 30033, Italy
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Rozzano, 20089, Italy
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Trento, 38100, Italy
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Treviglio, 24047, Italy
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Distrito Federal, 14080, Mexico
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Mérida, 97500, Mexico
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Monterrey, 64020, Mexico
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Monterrey, 64060, Mexico
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Panama City, 0, Panama
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Gdansk, 80-214, Poland
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Szczecin, 71-730, Poland
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Barcelona, 08035, Spain
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Lleida, 25198, Spain
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Sabadell, Barcelona, 08208, Spain
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Zaragoza, 50009, Spain
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Karlstad, 65185, Sweden
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Västerås, 72189, Sweden
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Ipswich, IP4 5PD, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Oxford, OX3 7LJ, United Kingdom
Unknown Facility
Southampton, SO16 6YD, United Kingdom
Unknown Facility
Weston-super-Mare, BS23 4TQ, United Kingdom
Related Publications (1)
Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
PMID: 34037241DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY CHAIR
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
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2016
First Posted
April 22, 2016
Study Start
February 1, 2002
Primary Completion
March 1, 2006
Study Completion
January 1, 2008
Last Updated
November 22, 2016
Results First Posted
November 22, 2016
Record last verified: 2016-09