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Sponsored by: |
Swiss Group for Clinical Cancer Research |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004935 |
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether combining monoclonal antibody therapy with chemotherapy is more effective than antibody therapy alone in treating patients with metastatic breast cancer.
PURPOSE: This randomized phase III trial is studying trastuzumab and paclitaxel to see how well they work compared to trastuzumab alone in treating women with metastatic breast cancer that overexpresses HER2.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: paclitaxel Drug: trastuzumab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Randomized Phase III Trial of Herceptin Followed by Taxol Plus Herceptin Versus the Combination of Herceptin and Taxol as First-Line Chemotherapy in Patients With HER2-Overexpressing Advanced Breast Cancer |
Estimated Enrollment: | 250 |
Study Start Date: | August 1999 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to degree of HER2/neu-overexpression (2+ vs 3+), prior anthracycline-containing adjuvant treatment (no prior treatment vs prior treatment without radiotherapy to left chest wall vs prior treatment with radiotherapy to left chest wall), estrogen-receptor status (positive vs negative vs unknown), prior therapy (first-line vs second/third-line), and center. Patients are randomized to one of two treatment arms.
Treatment continues in both arms in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and day 1 of courses 2, 3, 4, 5, 6, 8, 10 , and 12.
Patients are followed at 1, 3, and 6 months and then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 170-250 patients (85-125 per arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Clinically or radiologically measurable or evaluable disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
No concurrent bisphosphonates unless initiated more than 3 months prior to study
Italy | |
European Institute of Oncology | Recruiting |
Milan, Italy, 20141 | |
Contact: Aron Goldhirsch, MD 39-02-574-894-39 aron.goldhirsch@ibcsg.org | |
Switzerland | |
Centre Hospitalier Universitaire Vaudois | Recruiting |
Lausanne, Switzerland, CH-1011 | |
Contact: Lucien Perey, MD 41-21-314-0155 lucien.perey@chuv.hospvd.ch | |
Inselspital Bern | Recruiting |
Bern, Switzerland, CH-3010 | |
Contact: Stefan Aebi, MD 41-31-632-4114 stefan.aebi@insel.ch | |
Kantonspital Aarau | Recruiting |
Aarau, Switzerland, CH-5001 | |
Contact: Astrid Schonenberger, MD 41-62-838-6064 | |
Kantonsspital - St. Gallen | Recruiting |
St. Gallen, Switzerland, CH-9007 | |
Contact: Dagmar Hess, MD 41-71-494-1111 dagmar.hess@kssg.ch | |
Universitaetsspital-Basel | Recruiting |
Basel, Switzerland, CH-4031 | |
Contact: Christoph Rochlitz, MD 41-61-265-5059 crochlitz@uhbs.ch | |
Ospedale Beata Vergine | Recruiting |
Mendrisio, Switzerland, CH-6850 | |
Contact: Olivia Pagani, MD 41-91-811-3395 | |
Regionalspital | Recruiting |
Thun, Switzerland, 3600 | |
Contact: Daniel Rauch 41-33-226-2626 | |
UniversitaetsSpital Zuerich | Recruiting |
Zurich, Switzerland, CH-8091 | |
Contact: Bernhard Pestalozzi, MD 41-31-255-2214 | |
Kantonsspital Graubuenden | Recruiting |
Chur, Switzerland, CH-7000 | |
Contact: Roger von Moos, MD 41-81-256-6111 roger.vonmoos@ksgr.ch |
Study Chair: | Aron Goldhirsch, MD | European Institute of Oncology |
Study ID Numbers: | CDR0000067621, SWS-SAKK-22/99, EU-99028 |
Study First Received: | March 7, 2000 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00004935 |
Health Authority: | Unspecified |
stage IV breast cancer recurrent breast cancer |
Skin Diseases Paclitaxel Trastuzumab |
Breast Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |