NECTAR Everolimus Plus Cisplatin in Triple (-) Breast Cancer (NECTAR)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01931163|
Recruitment Status : Completed
First Posted : August 29, 2013
Results First Posted : July 9, 2021
Last Update Posted : July 20, 2021
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 combining Cisplatin chemotherapy with Everolimus is in treating subjects with triple negative breast cancer who have residual disease after chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Triple Negative Breast Cancer||Drug: Everolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Phase II Study Of Everolimus Plus Cisplatin In Triple Negative Breast Cancer Patients With Residual Disease After Standard Chemotherapy|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||January 2019|
|Actual Study Completion Date :||January 2019|
Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles Everolimus 10mg by mouth daily
- Tumor Response [ Time Frame: tumor response at 12 weeks after treatment ]
Evaluate tumor response using RECIST criteria after 12 weeks of treatment at definitive surgery.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01931163
|United States, Texas|
|The Methodist Hospital|
|Houston, Texas, United States, 77030|
|Houston Methodist Hospital Willowbrook|
|Houston, Texas, United States, 77070|
|Houston Methodist Hospital Sugar Land|
|Sugar Land, Texas, United States, 77479|
|Principal Investigator:||Jenny Chang, MD||The Methodist Hospital Research Institute|