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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Novartis |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00499603 |
Primary Objective:
Secondary Objectives:
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Paclitaxel Drug: 5-Fluorouracil Drug: Epirubicin Drug: Cyclophosphamide Drug: RAD001 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Open Label Randomized Clinical Trial of Standard Neoadjuvant Chemotherapy (Paclitaxel Followed by FEC) Versus the Combination of Paclitaxel and RAD001 Followed by FEC in Women With Triple Receptor-Negative Breast Cancer (CRAD001C24101) |
Estimated Enrollment: | 50 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Paclitaxel Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)
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Drug: Paclitaxel
80 mg/m^2 IV Once Weekly Over 1 Hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.
Drug: 5-Fluorouracil
500 mg/m^2 IV on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Drug: Epirubicin
100 mg/m^2 IV on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Drug: Cyclophosphamide
500 mg/m^2 IV on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
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2: Experimental
Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)
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Drug: Paclitaxel
80 mg/m^2 IV Once Weekly Over 1 Hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.
Drug: 5-Fluorouracil
500 mg/m^2 IV on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Drug: Epirubicin
100 mg/m^2 IV on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Drug: Cyclophosphamide
500 mg/m^2 IV on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Drug: RAD001
30 mg PO Weekly On Days 1, 8, & 15 for 12 cycles.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contact: Julia A Moore, RN, BSN | 713-563-0770 | jmoore@mdanderson.org |
Contact: Carol Stalzer, RN, BSN | 713-745-6806 | cstalzer@mdanderson.org |
United States, Texas | |
U.T. M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Julia A Moore, RN, BSN 713-563-0770 jmoore@mdanderson.org | |
Contact: Carol Stalzer, RN, BSN 713-745-6806 cstalzer@mdanderson.org | |
Principal Investigator: Ana Gonzalez-Angulo, M.D. |
Principal Investigator: | Ana Gonzalez-Angulo, M.D. | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Ana Gonzalez-Angulo, MD/Assistant Professor ) |
Study ID Numbers: | 2006-0790 |
Study First Received: | July 9, 2007 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00499603 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Breast Cancer ER negative PR negative HER2neu negative Tumor Triple Negative Receptors Paclitaxel Taxol |
RAD001 FEC 5-Fluorouracil 5-FU Epirubicin Cyclophosphamide |
Antimetabolites Everolimus Skin Diseases Immunologic Factors Breast Neoplasms Antimitotic Agents Cyclophosphamide Epirubicin Immunosuppressive Agents |
Anti-Bacterial Agents Paclitaxel Fluorouracil Tubulin Modulators Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neoplasms by Site Therapeutic Uses Alkylating Agents Breast Diseases Everolimus Skin Diseases |
Mitosis Modulators Breast Neoplasms Antimitotic Agents Immunosuppressive Agents Epirubicin Pharmacologic Actions Neoplasms Paclitaxel Fluorouracil Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |