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Sponsors and Collaborators: |
Sarah Cannon Research Institute SCRI Oncology Research Consortium Bristol-Myers Squibb |
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Information provided by: | Sarah Cannon Research Institute |
ClinicalTrials.gov Identifier: | NCT00789581 |
This is a randomized, Phase III, open-label, multicenter study.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: Doxorubicin Drug: Cyclophosphamide Drug: Ixabepilone (Ixempra) Drug: Paclitaxel (Taxol) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase III Study of Doxorubicin/Cyclophosphamide (AC) Followed by Ixabepilone vs. AC Followed by Paclitaxel in Patients With Triple-Negative Early-Stage Breast Cancer |
Estimated Enrollment: | 1800 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2016 |
Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by ixabepilone at 40 mg/m2 given for 4 cycles of 21 days each.
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Drug: Doxorubicin
Doxorubicin 60 mg/m2
Drug: Cyclophosphamide
Cyclophosphamide 600 mg/m2
Drug: Ixabepilone (Ixempra)
Ixabepilone 40 mg/m2
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2: Active Comparator
Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by paclitaxel at 80 mg/m2 weekly for 12 weeks.
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Drug: Doxorubicin
Doxorubicin 60 mg/m2
Drug: Cyclophosphamide
Cyclophosphamide 600 mg/m2
Drug: Paclitaxel (Taxol)
Paclitaxel 80 mg/m2
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Patients will be randomized in a 1:1 ratio to receive one of two different treatment arms. Patients in treatment arm 1 will receive AC followed by ixabepilone. Patients in treatment arm 2 will receive AC followed by weekly paclitaxel.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Early-stage breast cancer, defined as:
Definitive loco-regional surgery must have been completed as specified below:
Sentinel node biopsy and/or either lymph node sampling procedure or axillary dissection.
Patients with synchronous bilateral cancers are eligible only if:
HER2 negative tumors. HER2 negativity must be confirmed by one of the following:
Adequate hematologic function, defined by:
Adequate liver function, defined by:
Adequate renal function, defined by:
· Serum creatinine <=1.5 x ULN
Exclusion Criteria:
Contact: Denise A. Yardley, M.D. | (615) 329-7274 | dyardley@tnonc.com |
Contact: Trials Info | (615) 329-7274 | trialsinfo@scresearch.net |
United States, Florida | |
Florida Cancer Specialists | Recruiting |
Fort Myers, Florida, United States, 33901 | |
Contact: Katie Goodman 239-274-9930 KatieG@flcancer.com | |
United States, Tennessee | |
Tennessee Oncology, PLLC | Recruiting |
Nashville, Tennessee, United States, 37023 |
Responsible Party: | SCRI Oncology Research Consortium ( Denise Yardley, M.D. ) |
Study ID Numbers: | SCRI BRE 145, TITAN |
Study First Received: | November 11, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00789581 |
Health Authority: | United States: Food and Drug Administration |
Breast Cancer Adjuvant Doxorubicin Cyclophosphamide |
Paclitaxel Ixabepilone TITAN |
Skin Diseases Paclitaxel Epothilones Breast Neoplasms |
Cyclophosphamide Doxorubicin Breast Diseases |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |