NECTAR Everolimus Plus Cisplatin in Triple (-) Breast Cancer (NECTAR)
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|ClinicalTrials.gov Identifier: NCT01931163|
Recruitment Status : Active, not recruiting
First Posted : August 29, 2013
Last Update Posted : July 25, 2018
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 :||23 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|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||August 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: 2 years ]Evaluate tumor response using RECIST criteria before chemotherapy and every 6 weeks from the beginning of the treatment till disease progression.
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 System|