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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Hoffmann-La Roche Beth Israel Deaconess Medical Center Brigham and Women's Hospital Faulkner Hospital |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00148720 |
The purpose of this study is to find out what effects (good and bad) taking capecitabine for 12 weeks before surgery will have on women with breast cancer.
Condition | Intervention | Phase |
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Invasive Breast Carcinoma Primary Invasive Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Cancer |
Drug: Capecitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of Preoperative Capecitabine in Women With Operable Breast Cancer |
Estimated Enrollment: | 80 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | September 2009 |
Primary Completion Date: | September 2007 (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:
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02115 | |
Faulkner Hospital | |
Boston, Massachusetts, United States, 02130 |
Principal Investigator: | Ian Krop, MD, PhD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Ian Krop, MD, PhD ) |
Study ID Numbers: | 04-167 |
Study First Received: | September 7, 2005 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00148720 |
Health Authority: | United States: Institutional Review Board |
Invasive Breast Cancer Operable Breast Cancer Capecitabine |
Capecitabine Skin Diseases Breast Neoplasms |
Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Neoplasms by Site |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |