NECTAR Everolimus Plus Cisplatin in Triple (-) Breast Cancer
RATIONALE: Everolimus plus Cisplatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: The purpose of this study is to test how effective combing a Cisplatin chemotherapy with Everolimus is in treating subjects with residual triple negative breast cancer, who have already received chemotherapy prior to surgery.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||NEOADJUVANT PHASE II STUDY OF EVEROLIMUS PLUS CISPLATIN IN TRIPLE NEGATIVE BREAST CANCER PATIENTS WITH RESIDUAL DISEASE AFTER STANDARD CHEMOTHERAPY|
- tumor response [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Evaluate tumor response using RECIST criteria before chemotherapy and every 6 weeks from the begining of the treatment till disease progression.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles Everolimus 10mg by mouth daily
|Contact: Cancer Center Researchfirstname.lastname@example.org|
|United States, Texas|
|The Methodist Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Cancer Center Research 713-441-0629 email@example.com|
|Principal Investigator: Jenny Chang, MD|
|Principal Investigator:||Jenny Chang, MD||The Methodist Hospital System|