Paclitaxel, Carboplatin, and Panitumumab in Treating Patients With Metastatic Breast Cancer
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.
Recurrent Breast Cancer
Stage IV Breast Cancer
Procedure: laboratory biomarker analysis
Procedure: immunohistochemistry staining method
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria [ Time Frame: every 28 days for a minimum of 84 days ] [ Designated as safety issue: No ]Complete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules.
- Toxicity According to CTCAE v3.0 [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
- Time to Progression [ Time Frame: monthly ] [ Designated as safety issue: No ]
- Survival [ Time Frame: monthly ] [ Designated as safety issue: No ]
- Expression of EGFR and Other Protein Markers [ Time Frame: baseline ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||March 2016|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
Other Names:Drug: paclitaxel
Other Names:Drug: carboplatin
Other Names:Procedure: laboratory biomarker analysis
Correlative studyProcedure: immunohistochemistry staining method
Other Name: immunohistochemistry
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01009983
|United States, Louisiana|
|Ochsner Clinic Foundation|
|New Orleans, Louisiana, United States, 70115|
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Heidi D Klepin||Wake Forest School of Medicine|