Evidence map›Paper›PMID 42140950›Full record

Trial reportNature communications2026

Carboplatin with or without nivolumab in metastatic triple-negative breast cancer: a randomized phase II trial.

Ana C Garrido-Castro, Noah Graham, Katelyn X Li, Lynn Bi, Jett Crowdis, Kevin Bi, Jihye Park, Ricardo Pastorello, Yvonne Li, Hersh Gupta and 34 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03414684 (A Randomized Phase II Trial of Carboplatin With or Without Nivolumab in First-line Metastatic Triple-negative Breast Cancer), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT03414684 phase2active not recruitingnot on this map

A Randomized Phase II Trial of Carboplatin With or Without Nivolumab in First-line Metastatic Triple-negative Breast Cancer

TypeinterventionalSponsorDana-Farber Cancer InstituteRan2018 to 2026Enrolled78ConditionsBreast CancerArmsCarboplatin, Nivolumab
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

44 authors.

Ana C Garrido-CastroBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.ORCID http://orcid.org/0000-0002-5989-6636
Noah GrahamHarvard Medical School, Boston, MA, USA.
Katelyn X LiBroad Institute of MIT and Harvard, Cambridge, MA, USA.
Lynn BiBroad Institute of MIT and Harvard, Cambridge, MA, USA.
Jett CrowdisBroad Institute of MIT and Harvard, Cambridge, MA, USA.
Kevin BiBroad Institute of MIT and Harvard, Cambridge, MA, USA.
Jihye ParkBroad Institute of MIT and Harvard, Cambridge, MA, USA.
Ricardo PastorelloBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.
Yvonne LiDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.ORCID http://orcid.org/0000-0002-1741-1995
Hersh GuptaDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Thomas KuntzHarvard School of Public Health, Boston, MA, USA.
Russell PetryFoundation Medicine, Cambridge, MA, USA.
Lincoln W PasquinaFoundation Medicine, Cambridge, MA, USA.ORCID http://orcid.org/0009-0009-5461-9777
Ashka PatelBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.
Paulina LangeBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.
Molly DiLulloBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.
Victoria AttayaBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.
Anna Mae FreyBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.
Merrida A ChildressFoundation Medicine, Cambridge, MA, USA.ORCID http://orcid.org/0000-0002-0854-784X
Robert WesolowskiOhio State University Comprehensive Cancer Center, Columbus, OH, USA.
Natalie SinclairBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.
Sarah SinclairNorthern Light, Eastern Maine Medical Center, Bangor, ME, USA.
Steve LoStamford Hospital, Stamford, CT, USA.
Nadine TungHarvard Medical School, Boston, MA, USA.
Meredith FaggenBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.
Peter A KaufmanUniversity of Vermont Medical Center, Burlington, VT, USA.
Caroline C BlockBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.
Jeanna WalshBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.
Madhavi TokeUMass Memorial Medical Center, Worcester, MA, USA.
Wendy ChenBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.ORCID http://orcid.org/0000-0002-6946-1206
Kai W WucherpfennigHarvard Medical School, Boston, MA, USA.ORCID http://orcid.org/0000-0002-1829-302X
Ye TianDepartment of Cancer Immunology and Virology, Dana-Farber Cancer Institute, Boston, MA, USA.ORCID http://orcid.org/0000-0002-9655-7123
Amy J WilliamsBiovica Inc, San Diego, CA, USA.
Satabhisa Mukhopadhyay4D Path, Newton, MA, USA.
Tathagata Dasgupta4D Path, Newton, MA, USA.
Stuart SchnittBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.
Andrew D CherniackDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Romualdo BarrosoBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.
Jennifer LigibelBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.ORCID http://orcid.org/0000-0002-0633-3151
Nancy U LinBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.ORCID http://orcid.org/0000-0003-2263-5413
Elizabeth A MittendorfBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.ORCID http://orcid.org/0000-0002-9762-8536
Nabihah TayobHarvard Medical School, Boston, MA, USA.ORCID http://orcid.org/0000-0001-6088-167X
Eliezer Van AllenBroad Institute of MIT and Harvard, Cambridge, MA, USA.ORCID http://orcid.org/0000-0002-0201-4444
Sara M TolaneyBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA. sara_tolaney@dfci.harvard.edu.ORCID http://orcid.org/0000-0002-5940-8671

Funding

VectorP30CA006516 · NCI · DANA-FARBER CANCER INSTITUTE · PI Irene M. Ghobrial · 1985 to 2026
$330.6M
Targeting of a Major Immune Evasion Pathway in Triple-negative Breast CancerR01CA251599 · NCI · DANA-FARBER CANCER INST · PI WUCHERPFENNIG, KAI W · 2020 to 2024
$2.4M
NCI NIH HHS P30 CA006516NCI NIH HHS R01 CA251599
6 · The paper itself

Abstract

This multi-institutional randomized phase II clinical trial (NCT03414684) investigated the efficacy and safety of carboplatin plus nivolumab compared to carboplatin in metastatic triple-negative breast cancer (mTNBC). The primary endpoint was progression-free survival (PFS) in a modified intention-to-treat (mITT) population of patients with chemotherapy-naïve (i.e., first-line) mTNBC. Secondary endpoints included overall survival (OS), confirmed objective response rate, confirmed clinical benefit rate, time to and duration of confirmed objective response, safety, and tolerability. Clinical outcomes were evaluated in the PD-L1-positive subgroup ( ≥ 1% immune cells; SP142 clone) per central review. Biospecimens were collected for correlative analyses. 75 patients were enrolled and treated between 2/2018-9/2020. Among the mITT population (n = 62), median PFS was 4.2 months with carboplatin plus nivolumab vs 5.5 months with carboplatin. Median OS did not significantly differ between arms (16.8 vs 11.1 months, respectively). In PD-L1-positive mTNBC patients (n = 24), median PFS was 8.3 vs 4.7 months; median OS was 17.6 vs 10.7 months. Grade ≥3 adverse events occurred in 56.8% of patients in the combination arm and 65.8% in the carboplatin arm. Carboplatin plus nivolumab did not significantly improve PFS compared to carboplatin in patients overall; however, a trend toward improved outcomes was observed in PD-L1-positive mTNBC patients. High mutational burden, interferon-gamma signaling, early circulating tumor DNA reduction, low baseline serum thymidine kinase activity, and urea cycle dysregulation in the microbiome emerged as potential predictors of response to immune checkpoint inhibitors with platinum.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarboplatinNivolumabTriple Negative Breast NeoplasmsAdultAgedB7-H1 AntigenFemaleHumansMiddle AgedNeoplasm MetastasisProgression-Free SurvivalB7-H1 AntigenCarboplatinNivolumab

Identifiers

PMID42140950
PMCPMC13377202

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Registered trials

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.