A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer
NCT ID: NCT02748213
Last Updated: 2016-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
225 participants
INTERVENTIONAL
2002-02-28
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Herceptin + Taxotere
Participants will receive dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal.
Taxotere
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.
Herceptin
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.
Herceptin + Taxotere + Xeloda
Participants will receive triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal.
Xeloda
Participants will receive oral Xeloda, 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle.
Taxotere
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.
Herceptin
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.
Interventions
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Xeloda
Participants will receive oral Xeloda, 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle.
Taxotere
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.
Herceptin
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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%
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Adelaide, , Australia
Brisbane, , Australia
Camperdown, , Australia
Geelong, , Australia
Melbourne, , Australia
Melbourne, , Australia
Perth, , Australia
Southport, , Australia
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Calgary, Alberta, Canada
Ottawa, Ontario, Canada
Québec, Quebec, Canada
San José, , Costa Rica
Turku, , Finland
Besançon, , France
Grenoble, , France
Marseille, , France
Paris, , France
Pierre-Bénite, , France
Rennes, , France
Athens, , Greece
Heraklion, , Greece
Pátrai, , Greece
Guatemala City, , Guatemala
Legnago, , Italy
Noale, , Italy
Rozzano, , Italy
Trento, , Italy
Treviglio, , Italy
Distrito Federal, , Mexico
Mérida, , Mexico
Monterrey, , Mexico
Monterrey, , Mexico
Panama City, , Panama
Gdansk, , Poland
Szczecin, , Poland
Barcelona, , Spain
Lleida, , Spain
Sabadell, Barcelona, , Spain
Zaragoza, , Spain
Karlstad, , Sweden
Västerås, , Sweden
Ipswich, , United Kingdom
Leeds, , United Kingdom
Manchester, , United Kingdom
Northwood, , United Kingdom
Oxford, , United Kingdom
Southampton, , United Kingdom
Weston-super-Mare, , United Kingdom
Countries
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References
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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.
Other Identifiers
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MO16419
Identifier Type: -
Identifier Source: org_study_id