Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Dana-Farber Cancer Institute Massachusetts General Hospital Brigham and Women's Hospital North Shore Cancer Center Faulkner Hospital GlaxoSmithKline |
---|---|
Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00146549 |
The purpose of this study is to compare two different combinations of chemotherapy with trastuzumab as initial treatment for HER2 positive advanced breast cancer. Half of the patients will receive trastuzumab in combination with a taxane form of chemotherapy (either paclitaxel or docetaxel), while the other group will receive trastuzumab in combination with vinorelbine.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Stage IV Breast Cancer |
Drug: Trastuzumab Drug: Vinorelbine Drug: Paclitaxel Drug: Docetaxel |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Phase III Study of Trastuzumab (Herceptin) in Combination With Either Vinorelbine (Navelbine), or Taxane-Based Chemotherapy in Patients With HER2 Overexpressing Metastatic Breast Cancer |
Estimated Enrollment: | 250 |
Study Start Date: | August 2001 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Harold Burstein, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | 01-087 |
Study First Received: | September 2, 2005 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00146549 |
Health Authority: | United States: Institutional Review Board |
HER2-positive Breast cancer HER2 overexpressing trastuzumab Herceptin |
vinorelbine Navelbine Taxotere taxol |
Docetaxel Vinorelbine Skin Diseases Paclitaxel |
Trastuzumab Breast Neoplasms Taxane Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |