Evidence map›Paper›PMID 40295143›Full record

ArticleJournal for immunotherapy of cancer2025

Nivolumab and stereotactic radiosurgery for patients with breast cancer brain metastases: long-term results and biomarker analysis from a non-randomized, open-label, phase Ib study.

Kamran A Ahmed, Younchul Kim, Sungjune Kim, Min Hsuan Wang, Michelle DeJesus, John A Arrington, Aixa E Soyano, Avan J Armaghani, Ricardo L B Costa, Loretta S Loftus and 10 more

Registry-linked trialAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03807765 (Phase Ib Study of Stereotactic Radiation and Nivolumab in the Management of Metastatic Breast Cancer Brain Metastases), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT03807765 phase1completednot on this map

Phase Ib Study of Stereotactic Radiation and Nivolumab in the Management of Metastatic Breast Cancer Brain Metastases

TypeinterventionalSponsorH. Lee Moffitt Cancer Center and Research InstituteRan2019 to 2025Enrolled14ConditionsMetastatic Breast Cancer, Brain MetastasesArmsNivolumab, Stereotactic Radiosurgery
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Brain metastasis: Opportunities for novel therapies.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review
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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

20 authors.

Kamran A AhmedDepartment of Radiation Oncology, Moffitt Cancer Center, Tampa, Florida, USA Kamran.Ahmed@moffitt.org.ORCID http://orcid.org/0000-0003-3331-1529
Younchul KimDepartment of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, Florida, USA.
Sungjune KimDepartment of Radiation Oncology, Mayo Clinic Jacksonville Campus, Jacksonville, Florida, USA.
Min Hsuan WangDepartment of Radiation Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Michelle DeJesusDepartment of Radiation Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
John A ArringtonDepartment of Radiology, Moffitt Cancer Center, Tampa, Florida, USA.
Aixa E SoyanoDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Avan J ArmaghaniDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Ricardo L B CostaDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Loretta S LoftusDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Marilin RosaDepartment of Pathology, Moffitt Cancer Center, Tampa, Florida, USA.
Jimmy J CaudellDepartment of Radiation Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Roberto DiazDepartment of Radiation Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Arnold B EtameDepartment of Neuro Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Nam D TranDepartment of Neuro Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Hatem SolimanDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Brian J CzernieckiDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, Florida, USA.ORCID http://orcid.org/0000-0003-4519-9570
Peter A ForsythDepartment of Neuro Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Hsiang-Hsuan Michael YuDepartment of Radiation Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Hyo S HanDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, Florida, USA.

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI Christine O'Connell · 1998 to 2026
$93.5M
NCI NIH HHS P30 CA076292
6 · The paper itself

Abstract

backgroundWe hypothesized treatment with nivolumab and stereotactic radiosurgery (SRS) would be feasible, well tolerated, and may improve intracranial tumor control over SRS alone for breast cancer brain metastases (BCBM).

methodsThe study is a phase Ib trial of nivolumab and SRS for BCBM. CLINICAL TRIAL INFORMATION: NCT03807765. Key eligibility criteria include BCBM of all subtypes, age ≥18, Eastern Cooperative Oncology Group Performace Status (ECOG-PS)≤2 with ≤10 brain metastases. Treatment was initiated with a dose of nivolumab (480 mg intravenously) that was repeated every 4 weeks. The initial dose of nivolumab was followed 1 week later by SRS. Blood was collected at baseline and every 4 weeks for flow cytometry and cell-free DNA (cfDNA) assessment.

resultsA total of 12 patients received SRS to 17 brain metastases. Breast cancer subtypes included triple negative (50%), hormone receptor (HR)+/HER2- (33%), and HR-/HER2+ (17%). Median follow-up from start of protocol therapy is 56 months. No cases of radionecrosis were noted. Two lesions were noted to undergo local failure, both pathologically confirmed, for a 12-month local control of 94%. Median distant intracranial control was 7.4 months with a 12-month control rate of 33%. Median systemic progression-free survival was 7.7 months with a 12-month rate of 42%. Median overall survival (OS) was 24.7 months with a 12-month OS of 75%. Most patients were noted to have an increase in cfDNA throughout study treatment, at week 5 compared with baseline (83%), week 25 compared with baseline (89%), and 100% at first follow-up. Intracranial control was associated with lower levels of CD4 regulatory T cells (Treg) (p=0.03) and higher levels of CD4 T effector memory (p=0.04).

conclusionsNivolumab and SRS is a safe and feasible treatment option in BCBM. Long-term follow-up revealed no cases of radiation necrosis. TRIAL REGISTRATION NUMBER: NCT03807765.

Indexed as

Biomarkers, TumorBrain NeoplasmsBreast NeoplasmsNivolumabRadiosurgeryAdultAgedFemaleHumansMiddle AgedBiomarkers, TumorNivolumabBreast CancerImmunotherapyNivolumabRadiotherapy/radioimmunotherapy

Identifiers

PMID40295143
PMCPMC12039042

What OpenQuestion holds

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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.