Evidence map›Paper›PMID 40817986›Full record

Trial reportBreast cancer research and treatment2025

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

Rima Patel, Jami Fukui, Paula Klein, Erin Moshier, Hulya Kocyigit, Laura Fiedler, Weronika Bucwinska, Xiao Y Xing, Charles Shapiro, Anupama Goel and 8 more

Abstract readClinical Trial, Phase IIRandomized Controlled TrialComparative Study
PubMed Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Rima PatelDepartment of Medicine, Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, 1176 Fifth Ave, New York, NY, 10029, USA.
Jami FukuiUniversity of Hawaii Cancer Center, Honolulu, HI, USA.
Paula KleinDepartment of Medicine, Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, 1176 Fifth Ave, New York, NY, 10029, USA.
Erin MoshierDepartment of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Hulya KocyigitDepartment of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Laura FiedlerDepartment of Medicine, Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, 1176 Fifth Ave, New York, NY, 10029, USA.
Weronika BucwinskaDepartment of Medicine, Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, 1176 Fifth Ave, New York, NY, 10029, USA.
Xiao Y XingDepartment of Medicine, Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, 1176 Fifth Ave, New York, NY, 10029, USA.
Charles ShapiroDepartment of Medicine, Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, 1176 Fifth Ave, New York, NY, 10029, USA.
Anupama GoelDepartment of Medicine, Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, 1176 Fifth Ave, New York, NY, 10029, USA.
Julie FasanoDepartment of Medicine, Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, 1176 Fifth Ave, New York, NY, 10029, USA.
Theresa ShaoDepartment of Medicine, Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, 1176 Fifth Ave, New York, NY, 10029, USA.
Aarti BhardwajDepartment of Medicine, Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, 1176 Fifth Ave, New York, NY, 10029, USA.
Esther KimDepartment of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Rita VaccaroDepartment of Medicine, Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, 1176 Fifth Ave, New York, NY, 10029, USA.
Karen LeeDepartment of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Eric WilckDepartment of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Amy TierstenDepartment of Medicine, Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, 1176 Fifth Ave, New York, NY, 10029, USA. Amy.tiersten@mssm.edu.

Funding

NIH HHS 5P30CA196521
6 · The paper itself

Abstract

purposeTriple-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

methodsA 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.

resultsBetween 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.

conclusionThe 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.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarboplatinEverolimusTriple Negative Breast NeoplasmsAdultAgedAged, 80 and overFemaleHumansMiddle AgedNeoplasm StagingTreatment OutcomeCarboplatinEverolimusMetastaticTargeted therapyTriple negative breast cancer

Identifiers

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.