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| Sponsor: | Spanish Breast Cancer Research Group |
|---|---|
| Collaborator: |
Sanofi-Aventis |
| Information provided by: | Spanish Breast Cancer Research Group |
| ClinicalTrials.gov Identifier: | NCT00129376 |
Purpose
Treatment consists of 4 AC cycles followed by 2 weekly docetaxel cycles (12 infusions).
The pathological complete response rate obtained in previous studies is around 12%. The expected pathological complete response rate in this study is 25%. With an alpha error of 0.05 and a beta error of 0.2, and following Simon´s 2 phase test, 19 patients are needed initially. With 2 pathological complete responses, patient recruitment will continue until approximately 61 patients are recruited. Twelve pathological complete responses are needed to confirm the study hypothesis.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: docetaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter Phase II Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel (T) as Neoadjuvant Treatment for Operable Stage II and IIIA Breast Cancer Patients |
| Estimated Enrollment: | 63 |
| Study Start Date: | December 2002 |
| Estimated Study Completion Date: | July 2005 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Spain | |
| Spanish Breast Cancer Research Group | |
| San Sebastián de los Reyes, Madrid, Spain, 28700 | |
| Study Chair: | Laura García-Estévez, MD | Spanish Breast Cancer Research Group (GEICAM) |
More Information
| ClinicalTrials.gov Identifier: | NCT00129376 History of Changes |
| Other Study ID Numbers: | GEICAM 2002-03 |
| Study First Received: | August 10, 2005 |
| Last Updated: | September 7, 2005 |
| Health Authority: | Spain: Spanish Agency of Medicines |
|
Stage II and IIIA breast Cancer. Neoadjuvant chemotherapy. Weekly docetaxel. |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Docetaxel Doxorubicin Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic |