Paclitaxel, Carboplatin, and Panitumumab in Treating Patients With Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT01009983|
Recruitment Status : Terminated (Slow accrual)
First Posted : November 9, 2009
Results First Posted : June 18, 2014
Last Update Posted : February 15, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer||Biological: panitumumab Drug: paclitaxel Drug: carboplatin Procedure: laboratory biomarker analysis Procedure: immunohistochemistry staining method||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2010|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||December 2013|
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
- Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria [ Time Frame: 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.
- Time to Progression [ Time Frame: 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.
- Survival [ Time Frame: Approximately 7 months ]
- Expression of EGFR and Other Protein Markers [ Time Frame: baseline ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 University Health Sciences|