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Sponsored by: |
Leo W. Jenkins Cancer Center |
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Information provided by: | Leo W. Jenkins Cancer Center |
ClinicalTrials.gov Identifier: | NCT00542191 |
This neoadjuvant chemotherapy protocol focusing on "triple-negative" breast cancers alone will gather a foundation of primary tumor and axillary lymph nodal response to primary chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome data. This comparative data can then be used in building subsequent trials.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin Procedure: Definitive Surgery Radiation: Radiotherapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer |
Estimated Enrollment: | 28 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Women with a diagnosed "triple-negative" proxy of basal-like breast cancer confirmed on a core biopsy and larger than 2 cm will be treated neoadjuvantly with the Livingston metronomic regimen of 12 weeks of weekly doxorubicin 24 mg/m2 and daily oral cyclophosphamide 60 mg/m2 followed by 12 successive weeks of taxol 80 mg/m2 and carboplatin AUC 2. Although clinical response will be evaluated prior to surgery, the primary end-point is the pathologic response. Secondary end-points will be DFS and OS based upon standard of care surveillance. A pathologic complete response (pCR) will require no histologic evidence of residual malignant cells seen in the primary tumor area specimen or the lymph nodes. Standard of care surgery and radiation therapy will be undertaken.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paul Walker, MD | 252-744-1888 | walkerp@ecu.edu |
Contact: Melinda Friday, RN, OCN | 252-744-1015 | fridaym@ecu.edu |
United States, North Carolina | |
Brody School of Medicine at East Carolina University | Recruiting |
Greenville, North Carolina, United States, 27834 |
Principal Investigator: | Paul Walker, MD | Brody School of Medicine at East Carolina University |
Responsible Party: | East Carolina University ( Paul Walker, MD ) |
Study ID Numbers: | LJCC 07-03 |
Study First Received: | October 9, 2007 |
Last Updated: | February 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00542191 History of Changes |
Health Authority: | United States: Institutional Review Board |
Triple negative (ER/PR negative; HER2 negative) |
Skin Diseases Immunologic Factors Breast Neoplasms Antimitotic Agents Cyclophosphamide Carboplatin Immunosuppressive Agents Doxorubicin |
Anti-Bacterial Agents Paclitaxel Tubulin Modulators Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Breast Diseases |
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 Skin Diseases Mitosis Modulators Breast Neoplasms |
Carboplatin Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Doxorubicin Neoplasms Paclitaxel Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |