Evidence map›Paper›PMID 38869771›Full record

Trial reportBreast cancer (Tokyo, Japan)2024

Neoadjuvant talazoparib in patients with germline BRCA1/2 mutation-positive, early-stage triple-negative breast cancer: exploration of tumor BRCA mutational status.

Melinda L Telli, Jennifer K Litton, J Thaddeus Beck, Jason M Jones, Jay Andersen, Lida A Mina, Raymond Brig, Michael Danso, Yuan Yuan, William F Symmans and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Breast cancer (Tokyo, Japan), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03499353 (A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER), which is not on this 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.

NCT03499353 phase2terminatednot on this map

A phase 2, non randomized, open label, single arm, multi center study of talazoparib for neoadjuvant treatment of germline brca1/2 mutation patients with early human epidermal growth factor receptor 2 negative breast cancer

TypeinterventionalSponsorPfizerRan2018 to 2020Enrolled61ConditionsEarly Breast CancerArmsTALAZOPARIB
3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Monitoring Pharmacological Treatment of Breast Cancer with MRI.Current issues in molecular biology · 2025
    Review
  6. Therapeutic Targeting of DNA Damage Response Pathways inBrain tumor research and treatment · 2025
    Review
  7. Review
  8. Review
  9. 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

17 authors.

Melinda L TelliDepartment of Medicine, Stanford University School of Medicine, Stanford, CA, USA. mtelli@stanford.edu.ORCID http://orcid.org/0000-0001-7993-1235
Jennifer K LittonDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
J Thaddeus BeckDepartment of Medical Oncology and Hematology, Highlands Oncology, Springdale, AR, USA.
Jason M JonesAvera Medical Group Oncology & Hematology, Avera Cancer Institute, Sioux Falls, SD, USA.
Jay AndersenMedical Oncology, Compass Oncology, West Cancer Center, US Oncology Network, Tigard, OR, USA.
Lida A MinaHematology Oncology Department, Banner MD Anderson Cancer Center, Gilbert, AZ, USA.
Raymond BrigMedical Oncology, Brig Center for Cancer Care and Survivorship, Knoxville, TN, USA.
Michael DansoMedical Oncology, Virginia Oncology Associates, Norfolk, VA, USA.
Yuan YuanDepartment of Medical Oncology & Therapeutics Research, Cedars-Sinai Cancer Center, West Hollywood, CA, USA.
William F SymmansDepartment of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Julia F HopkinsFoundation Medicine, Inc., Cambridge, MA, USA.
Lee A AlbackerFoundation Medicine, Inc., Cambridge, MA, USA.
Antonello AbbattistaClinical Statistics, Pfizer Oncology, Milan, Italy.
Kay NoonanClinical Oncology, Pfizer Inc., Groton, CT, USA.
Marielena MataPfizer Inc., La Jolla, CA, USA.
A Douglas LairdPfizer Inc., South San Franciso, CA, USA.
Joanne L BlumDepartment of Oncology, Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas, TX, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTalazoparib monotherapy in patients with germline BRCA-mutated, early-stage triple-negative breast cancer (TNBC) showed activity in the neoadjuvant setting in the phase II NEOTALA study (NCT03499353). These biomarker analyses further assessed the mutational landscape of the patients enrolled in the NEOTALA study.

methodsBaseline tumor tissue from the NEOTALA study was tested retrospectively using FoundationOne

resultsAll patients enrolled (N = 61) had TNBC. In the biomarker analysis population, 75.0% (39/52) and 25.0% (13/52) of patients exhibited BRCA1 and BRCA2 mutations, respectively. Strong concordance (97.8%) was observed between tumor BRCA and germline BRCA mutations, and 90.5% (38/42) of patients with tumor BRCA mutations evaluable for somatic-germline-zygosity were predicted to exhibit BRCA loss of heterozygosity (LOH). No patients had non-BRCA germline DNA damage response (DDR) gene variants with known/likely pathogenicity, based on a panel of 14 non-BRCA DDR genes. Ninety-eight percent of patients had TP53 mutations. Genomic LOH, assessed continuously or categorically, was not associated with response.

conclusionThe results from this exploratory biomarker analysis support the central role of BRCA and TP53 mutations in tumor pathobiology. Furthermore, these data support assessing germline BRCA mutational status for molecular eligibility for talazoparib in patients with TNBC.

Indexed as

BRCA1 ProteinBRCA2 ProteinGerm-Line MutationNeoadjuvant TherapyPhthalazinesTriple Negative Breast NeoplasmsAdultAgedBiomarkers, TumorFemaleHumansLoss of HeterozygosityMiddle AgedRetrospective StudiesBiomarkers, TumorBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humanPhthalazinestalazoparibBRCA1BRCA2NeoadjuvantTalazoparibTriple-negative breast cancer

Identifiers

PMID38869771
PMCPMC11341741

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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.