Evidence map›Paper›PMID 37318349›Full record

Trial reportThe oncologist2023

Neoadjuvant Talazoparib in Patients With Germline BRCA1/2 Mutation-Positive, Early-Stage Triple-Negative Breast Cancer: Results of a Phase II Study.

Jennifer K Litton, J Thaddeus Beck, Jason M Jones, Jay Andersen, Joanne L Blum, Lida A Mina, Raymond Brig, Michael Danso, Yuan Yuan, Antonello Abbattista and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in The oncologist, 2023. 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 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
11.0field-weighted citation impact, top 1% of its field
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

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

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  20. Early breast cancer in youngTherapeutic advances in medical oncology · 2025
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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

16 authors at 11 institutions in 3 countries.

Jennifer K LittonDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0001-8390-4985
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.
Joanne L BlumDepartment of Oncology, Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas, TX, 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.ORCID 0000-0001-7440-8939
Antonello AbbattistaClinical Statistics, Pfizer Oncology, Milan, Italy.
Kay NoonanClinical Oncology, Pfizer Inc., Groton, CT, USA.
Alexander NiyazovOncology Value & Evidence, Pfizer Inc., New York, NY, USA.
Jayeta ChakrabartiMedical Oncology, Pfizer Ltd., Walton Oaks, Surrey, UK.
Akos CzibereOncology Drug Development, Pfizer Inc., Cambridge, MA, USA.
William F SymmansDepartment of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Melinda L TelliDepartment of Medicine, Stanford University School of Medicine, Stanford, CA, USA.
Pfizer (United States) · USThe University of Texas MD Anderson Cancer Center · USAvera Health · USCedars-Sinai Medical Center · USCompass Oncology · USHighlands Oncology Group · USPfizer (Italy) · ITPfizer (United Kingdom) · GBStanford University · USTexas Oncology · USVirginia Oncology Associates · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe undetermined efficacy of the current standard-of-care neoadjuvant treatment, anthracycline/platinum-based chemotherapy, in patients with early-stage triple-negative breast cancer (TNBC) and germline BRCA mutations emphasizes the need for biomarker-targeted treatment, such as poly(ADP-ribose) polymerase inhibitors, in this setting. This phase II, single-arm, open-label study evaluated the efficacy and safety of neoadjuvant talazoparib in patients with germline BRCA1/2-mutated early-stage TNBC. PATIENTS AND

methodsPatients with germline BRCA1/2-mutated early-stage TNBC received talazoparib 1 mg once daily for 24 weeks (0.75 mg for moderate renal impairment) followed by surgery. The primary endpoint was pathologic complete response (pCR) by independent central review (ICR). Secondary endpoints included residual cancer burden (RCB) by ICR. Safety and tolerability of talazoparib and patient-reported outcomes were assessed.

resultsOf 61 patients, 48 received ≥80% talazoparib doses, underwent surgery, and were assessed for pCR or progressed before pCR assessment and considered nonresponders. pCR rate was 45.8% (95% confidence interval [CI], 32.0%-60.6%) and 49.2% (95% CI, 36.7%-61.6%) in the evaluable and intent-to-treat (ITT) population, respectively. RCB 0/I rate was 45.8% (95% CI, 29.4%-63.2%) and 50.8% (95% CI, 35.5%-66.0%) in the evaluable and ITT population, respectively. Treatment-related adverse events (TRAE) were reported in 58 (95.1%) patients. Most common grade 3 and 4 TRAEs were anemia (39.3%) and neutropenia (9.8%). There was no clinically meaningful detriment in quality of life. No deaths occurred during the reporting period; 2 deaths due to progressive disease occurred during long-term follow-up (>400 days after first dose).

conclusionsNeoadjuvant talazoparib monotherapy was active despite pCR rates not meeting the prespecified threshold; these rates were comparable to those observed with combination anthracycline- and taxane-based chemotherapy regimens. Talazoparib was generally well tolerated. CLINICALTRIALS.GOV IDENTIFIER: NCT03499353.

Indexed as

BRCA1 ProteinTriple Negative Breast NeoplasmsAnthracyclinesAntineoplastic Combined Chemotherapy ProtocolsBRCA2 ProteinGerm-Line MutationHumansNeoadjuvant TherapyPhthalazinesPoly(ADP-ribose) Polymerase InhibitorsQuality of LifeAnthracyclinesBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humanPhthalazinesPoly(ADP-ribose) Polymerase Inhibitorstalazoparibantineoplastic agentsneoadjuvant therapypoly(ADP-ribose) polymerase inhibitorstriple-negative breast neoplasms

Identifiers

PMID37318349
PMCPMC10546823
OpenAlexW4380730083

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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.