Evidence map›Paper›PMID 39908010›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2025

A Phase II Study of Abemaciclib for Patients with Retinoblastoma-Positive, Metastatic Triple-Negative Breast Cancer.

Shom Goel, Bojana Jovanović, Xiangying Chu, Melissa Hughes, Timothy K Erick, Douglas Russo, Molly DiLullo, Eileen Wrabel, Rinath Jeselsohn, Nancy U Lin and 4 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Regulation of the immune CD155-CD226-TIGIT axis by cyclin D-CDK4/6.Proceedings of the National Academy of Sciences of the United States of America · 2026
    Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Genomic Predictive Biomarkers in Breast Cancer: TheInternational journal of molecular sciences · 2025
    Review
  10. Review
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

14 authors.

Shom Goel *Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0000-0001-8329-9084
Bojana Jovanović *Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0000-0002-6971-4525
Xiangying ChuDepartment of Data Science, Dana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0009-0000-3474-3804
Melissa HughesDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0000-0001-6190-9101
Timothy K ErickDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0000-0002-6855-2528
Douglas RussoDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0000-0002-2502-1540
Molly DiLulloDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0009-0005-1036-796X
Eileen WrabelDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0009-0009-7930-9919
Rinath JeselsohnDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0000-0001-7996-7529
Nancy U LinDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0000-0003-2263-5413
Nabihah TayobHarvard Medical School, Boston, Massachusetts.ORCID 0000-0001-6088-167X
Elizabeth MittendorfBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, Massachusetts.ORCID 0000-0002-9762-8536
Stuart SchnittBreast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, Massachusetts.ORCID 0000-0002-3608-7828
Sara M TolaneyDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0000-0002-5940-8671

Funding

Eli Lilly and Company (Lilly)National Health and Medical Research Council (NHMRC) GNT1177357OOFOSSnow Medical (SnowMedical) SF2020-47
6 · The paper itself

Abstract

purposeCyclin-dependent kinase 4/6 inhibitors can significantly extend survival when given in combination with endocrine therapy in patients with hormone receptor-positive metastatic breast cancer. However, their activity has been relatively underexplored in patients with metastatic triple-negative breast cancer (mTNBC). PATIENTS AND

methodsWe conducted a single-arm phase II study of abemaciclib monotherapy in patients with Rb-positive mTNBC. Patients were treated with abemaciclib 200 mg orally twice daily until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was the objective response rate; secondary endpoints included progression-free survival (PFS), overall survival (OS), clinical benefit rate, disease control rate, and safety and tolerability.

resultsA total of 27 patients were enrolled before the trial was closed early because of slow accrual. Patients had received a median of two lines of systemic therapy in the metastatic setting prior to enrollment. After a median follow-up of 28.5 months, the objective response rate was 0%, the clinical benefit rate was 14.8%, and the disease control rate was 22.2%. The median PFS was 1.94 months (95% confidence interval, 1.84-11.47), and the median OS was 8.44 months (95% confidence interval, 4.57-15.57). Median PFS and OS did not differ significantly based on androgen receptor and PD-L1 status. Pretreatment gene expression profiling of tumor tissue provided some hypothesis-generating insights into biological features associated with clinical benefit in this study. The most common treatment-related adverse events of grade 2 or higher were diarrhea (40.7%), neutropenia (40.7%), anemia (29.6%), and nausea (29.6%).

conclusionsAbemaciclib monotherapy did not show clinical activity in patients with pretreated Rb-positive mTNBC.

Indexed as

AminopyridinesBenzimidazolesRetinoblastoma ProteinTriple Negative Breast NeoplasmsAdultAgedBiomarkers, TumorFemaleHumansMiddle AgedNeoplasm MetastasisTreatment OutcomeabemaciclibAminopyridinesBenzimidazolesBiomarkers, TumorRetinoblastoma Protein

Identifiers

PMID39908010
PMCPMC11995003

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.