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Sponsors and Collaborators: |
US Oncology Research Sanofi-Aventis |
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Information provided by: | US Oncology Research |
ClinicalTrials.gov Identifier: | NCT00493870 |
The purpose of this research study is to find out what effects (good and bad) TC or TAC has on you and your early stage HER2- breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: Taxotere Drug: Adriamycin Drug: Cytoxan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Phase III Trial of TC Versus TAC in HER2-Negative Early Stage Breast Cancer Patients |
Estimated Enrollment: | 2000 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2015 |
Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A woman will be eligible for inclusion in this study if she meets all of the following criteria:
Meets 1 of the 3 following criteria:
Exclusion Criteria:
A woman will be excluded from this study if she meets any of the following criteria:
Contact: Tamara Orr | 832-348-5579 | Tamara.Orr@USOncology.com |
Contact: Laura Guerra | 832-348-5275 | Laura.Guerra@USOncology.com |
Principal Investigator: | Joanne L Blum, MD | US Oncology Research |
Responsible Party: | US Oncology Research, Inc. ( Regulatory Manager ) |
Study ID Numbers: | 11271 |
Study First Received: | June 27, 2007 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00493870 |
Health Authority: | United States: Institutional Review Board |
Docetaxel Skin Diseases Breast Neoplasms |
Cyclophosphamide Doxorubicin Breast Diseases |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |