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Brief Title: Paclitaxel, Carboplatin, and Panitumumab in Treating Patients With Metastatic Breast Cancer
Official Title: A Phase II Clinical Trial of Weekly Paclitaxel and Carboplatin in Combination With Panitumumab in Metastatic Breast Cancer Patients With Triple Negative Disease
Study ID: NCT01009983
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Other find tumor cells and help kill them or carry tumor-killing substances to them. Giving panitumumab together with paclitaxel and carboplatin may be a better way to block tumor growth. PURPOSE: This phase II trial is studying the side effects and how well paclitaxel and carboplatin together with panitumumab works in treating patients with metastatic triple negative breast cancer.
Detailed Description: PRIMARY OBJECTIVE: I. To determine the response rate to the combination of carboplatin, paclitaxel and panitumumab in women with ER-, PR- and Her-2 negative metastatic breast cancer. SECONDARY OBJECTIVES: I. To determine the tolerability and toxicities of the combination of paclitaxel, carboplatin and panitumumab. II. To determine the markers that co-occur with EGFR expression in the triple negative breast cancer. III. To assess the association between tumor biomarkers and clinical outcomes (response and survival). IV. To examine the effect this regimen has on time to progression and survival. OUTLINE: Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Name: Heidi D Klepin
Affiliation: Wake Forest University Health Sciences
Role: PRINCIPAL_INVESTIGATOR