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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Brigham and Women's Hospital Beth Israel Deaconess Medical Center Genentech |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00542451 |
The purpose of this study is to find out what effect the postoperative combination of therapies: trastuzumab (herceptin) and paclitaxel (taxol) will have on breast cancer recurrence. A combination of trastuzuamb and chemotherapy has been used in women with node positive and high risk node negative disease. This tests utilizes a well tolerated regimen of weekly paclitaxel and trastuzumab in women with T1, node negative tumors that are HER2 positive. We would like to determine how effective this drug combination is when used in women with early stage breast cancer, as well as to better define the side effects of this treatment.
Condition | Intervention | Phase |
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Breast Cancer Carcinoma of the Breast |
Drug: Paclitaxel Drug: Trastuzumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Trial of Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer |
Estimated Enrollment: | 400 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eric Winer, MD | 617-632-3800 | ewinder@partners.org |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Eric Winer, MD 617-632-3800 ewiner@partners.org | |
Principal Investigator: Eric Winer, MD | |
Beth Israel Deaconess Medical Center | Not yet recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Steven Come, MD 617-667-4599 scome@bidmc.harvar.edu | |
Principal Investigator: Steven Come, MD |
Principal Investigator: | Eric Winer, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Eric Winer, MD ) |
Study ID Numbers: | 07-199 |
Study First Received: | October 9, 2007 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00542451 |
Health Authority: | United States: Institutional Review Board |
node-negative breast cancer HER-2 positive |
Skin Diseases Paclitaxel Trastuzumab Breast Neoplasms |
Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |