Paclitaxel, Carboplatin, and Panitumumab in Treating Patients With Metastatic Breast Cancer
- Conditions
- Stage IV Breast CancerBreast CancerRecurrent Breast Cancer
- Interventions
- Biological: panitumumabProcedure: laboratory biomarker analysisProcedure: immunohistochemistry staining method
- Registration Number
- NCT01009983
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 14
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 laboratory biomarker analysis Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15. Arm 1 immunohistochemistry staining method Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15. Arm 1 panitumumab Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15. Arm 1 carboplatin Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15. Arm 1 paclitaxel Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
- Primary Outcome Measures
Name Time Method Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria every 28 days for a minimum of 84 days Complete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules.
- Secondary Outcome Measures
Name Time Method Survival Approximately 7 months Time to Progression Approximately 7 months Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Expression of EGFR and Other Protein Markers baseline
Trial Locations
- Locations (2)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States