Women's MoonShot: Neoadjuvant Treatment With PaCT for Patients With Locally Advanced TNBC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02593175|
Recruitment Status : Recruiting
First Posted : October 30, 2015
Last Update Posted : June 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Estrogen Receptor Negative HER2/Neu Negative Progesterone Receptor Negative Stage I Breast Cancer AJCC v7 Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage II Breast Cancer AJCC v6 and v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Stage III Breast Cancer AJCC v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Triple-Negative Breast Carcinoma||Drug: Carboplatin Other: Laboratory Biomarker Analysis Drug: Paclitaxel Biological: Panitumumab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Women's Triple-Negative First-Line Study: A Phase II Trial of Panitumumab, Carboplatin and Paclitaxel (PaCT) in Patients With Localized Triple-Negative Breast Cancer (TNBC) With Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy|
|Actual Study Start Date :||August 26, 2016|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||August 31, 2021|
Experimental: Treatment (panitumumab, paclitaxel, carboplatin)
Patients receive panitumumab IV over 30 minutes and paclitaxel IV over 30 minutes on days 1, 8, and 15. Patients also receive carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Pathologic compete response (pCR) (residual cancer burden [RCB]-0) or RCB-I response rates of patients with localized triple-negative breast cancer (TNBC) treated with panitumumab, carboplatin and paclitaxel (PaCT) [ Time Frame: Up to 2 years ]Will estimate the proportion of patients with pCR (RCB-0) or RCB-I as the response rate along with an appropriate 95% confidence interval. Will estimate the proportion of patients in the remaining RCB categories with confidence intervals as well.
- Progression free survival (PFS) [ Time Frame: Time from enrollment to progression of disease (> 20% increase in tumor size) or death whichever comes first, assessed up to 2 years ]PFS distribution will be estimated using the Kaplan-Meier method.
- Changes of EGFR levels [ Time Frame: Baseline up to 1 week after 1 dose of panitumumab ]Potential biomarkers of response will be correlated with pathologic response to this treatment using appropriate statistical analyses for the biomarker of interest.
- Pathologic complete response (pCR) (residual cancer burden [RCB]-0) or RCB-I response rates of patients treated with panitumumab, carboplatin and paclitaxel (PaCT), assessed by radiographic imaging [ Time Frame: Up to 4 courses (84 days) ]The proportion of patients with pCR (RCB-0) or RCB-I as the response rate will be estimated along with an appropriate 95% confidence interval. The proportion of patients in the remaining RCB categories will be estimated with confidence intervals.
- Overall survival (OS) [ Time Frame: Up to 2 years after completion of study treatment ]OS distribution will be estimated using the Kaplan-Meier method.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593175
|Contact: Bora Lim, MD||713-792-2817||BLim@mdanderson.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Bora Lim 713-792-2817|
|Principal Investigator: Bora Lim|
|Principal Investigator:||Bora Lim||M.D. Anderson Cancer Center|