10 Sep ICAHN Mt. Sinai Study: Combination Chemotherapy Trial Demonstrated Reduced Progression of Triple Negative Breat Cancer
MedicalResearch.com Interview with:

Dr. Patel
Rima Patel, MD
Assistant Professor
The Tisch Cancer Institute, Division of Hematology/Oncology
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Targeted treatment options for metastatic triple negative breast cancer (TNBC) are limited. TNBCs are associated with a high frequency of PTEN loss, which can lead to activation of the mTOR pathway and tumor proliferation but may be reversible with the mTOR inhibitor everolimus. A prior phase II single arm trial of carboplatin and everolimus in patients with advanced TNBC demonstrated good tolerability and preliminary efficacy. The current study is a randomized phase II trial comparing carboplatin and everolimus with carboplatin alone in patients with metastatic TNBC.
We found that the combination of carboplatin and everolimus reduced the risk of progression or death by 52%. The regimen was well tolerated and provides a promising treatment option for patients with advanced TNBC.
MedicalResearch.com: Are these medications already commercially available?
Response: Both carboplatin and everolimus are commercially available. However, everolimus is only approved for the treatment of hormone receptor-positive, HER2-negative breast cancer and not triple negative breast cancer. In addition, the combination of the drugs is not yet approved.
MedicalResearch.com: What should readers take away from your report?
Response: The combination of carboplatin and everolimus can be considered for patients with metastatic TNBC as it was found to be safe and effective in our study. However, further data on the combination is needed in a larger phase III clinical trial before it can be used in clinical practice.
MedicalResearch.com: What recommendations do you have for future research as a results of this study?
Response: We would recommend that a phase III randomized clinical trial be conducted in a larger population to evaluate the efficacy of carboplatin and everolimus compared to carboplatin alone.
Disclosures: Novartis provided the drug everolimus for the clinical trial.
Citation:
Patel R, Fukui J, Klein P, Moshier E, Kocyigit H, Fiedler L, Bucwinska W, Xing XY, Shapiro C, Goel A, Fasano J, Shao T, Bhardwaj A, Kim E, Vaccaro R, Lee K, Wilck E, Tiersten A. Randomized phase II comparison of single-agent carboplatin versus combination of carboplatin and everolimus for advanced triple negative breast cancer. Breast Cancer Res Treat. 2025 Aug 16. doi: 10.1007/s10549-025-07802-7. Epub ahead of print. PMID: 40817986.
https://pubmed.ncbi.nlm.nih.gov/40817986/
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Last Updated on September 10, 2025 by Marie Benz MD FAAD