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. 2025 Aug 16.
doi: 10.1007/s10549-025-07802-7. Online ahead of print.

Randomized phase II comparison of single-agent carboplatin versus combination of carboplatin and everolimus for advanced triple negative breast cancer

Rima Patel  1 , Jami Fukui  2 , Paula Klein  1 , Erin Moshier  3 , Hulya Kocyigit  3   4 , Laura Fiedler  1 , Weronika Bucwinska  1 , Xiao Y Xing  1 , Charles Shapiro  1 , Anupama Goel  1 , Julie Fasano  1 , Theresa Shao  1 , Aarti Bhardwaj  1 , Esther Kim  5 , Rita Vaccaro  1 , Karen Lee  6 , Eric Wilck  6 , Amy Tiersten  7
Affiliations

Randomized phase II comparison of single-agent carboplatin versus combination of carboplatin and everolimus for advanced triple negative breast cancer

Rima Patel et al. Breast Cancer Res Treat. .

Abstract

Purpose: Triple-negative breast cancers (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.

Patients and methods: A phase II randomized trial in patients with advanced TNBC, with 0-3 prior lines of therapy, was conducted. Patients were randomized 2:1 to receive carboplatin and everolimus or carboplatin alone. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), overall response rate (ORR), clinical benefit rate (CBR), and safety.

Results: Between 2015 and 2022, 59 patients were randomized to carboplatin/everolimus (n = 38) or carboplatin alone (n = 21). The median age of the population was 62 years and 68% had received at least one prior line of therapy. Median PFS was significantly improved in patients who received carboplatin/everolimus (4.7 months) versus carboplatin alone (4.2 months; HR:0.49; 95% CI: 0.25-0.98; p = 0.0390). OS was 17.6 months with the combination and 14.6 months with carboplatin alone (HR:1.17; 95% CI: 0.59-2.30; p = 0.6593). The most common adverse events (AEs) on the combination included thrombocytopenia, anemia, leukopenia, and neutropenia.

Conclusion: The combination of carboplatin and everolimus in this study 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.

Keywords: Metastatic; Targeted therapy; Triple negative breast cancer.

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Conflict of interest statement

Declarations. Competing interests: A.T. reports a consulting/advisory role for Puma Biotechnology, Immunomedics, AstraZeneca, Novartis, eisai and Roche/Genentech. All other authors report no relevant conflicts of interest. Ethical approval: The protocol was approved by the Icahn School of Medicine at Mount Sinai’s Institutional Review Boards and conducted in accordance with the Declaration of Helsinki. Informed consent: All patients provided written informed consent.

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