Evidence map›Paper›PMID 38904892›Full record

Observational studyBreast cancer research and treatment2024

Real-world use patterns, effectiveness, and tolerability of sacituzumab govitecan for second-line and later-line treatment of metastatic triple-negative breast cancer in the United States.

Kevin Kalinsky, Laura Spring, Clinton Yam, Manali Ajay Bhave, Ioanna Ntalla, Catherine Lai, Nikoleta Sjekloca, Brian Stwalley, Michael Stokes, Aliki Taylor and 1 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in Breast cancer research and treatment, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02574455 (An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients With Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
–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.

NCT02574455 phase3completednot on this map

An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients With Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments

TypeinterventionalSponsorGilead SciencesRan2017 to 2020Enrolled529ConditionsBreast CancerArmsSacituzumab govitecan, Eribulin, Capecitabine, Gemcitabine, Vinorelbine
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Primary G-CSF prophylaxis in sacituzumab govitecan-treated mTNBC: real-world evidence from a multinational CEBCC-102 cohort.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
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  9. Impact of GermlineOncology research · 2026
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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

11 authors.

Kevin KalinskyDepartment of Medical Oncology, Winship Cancer Institute, Emory University, 1365 Clifton Road Northeast, Bldg C, Fl 2, Atlanta, GA, 30322, USA. kevin.michael.kalinsky@emory.edu.ORCID http://orcid.org/0000-0002-1583-3553
Laura SpringDivision of Hematology/Oncology, Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA, USA.
Clinton YamDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Manali Ajay BhaveBreast Oncology Program, Winship Cancer Institute, Emory University, Atlanta, GA, USA.
Ioanna NtallaReal-World Evidence, Gilead Sciences Europe Ltd., Stockley Park, UK.
Catherine LaiClinical Development, Gilead Sciences, Inc., Foster City, CA, USA.
Nikoleta SjeklocaGlobal Medical Affairs, Gilead Sciences Europe Ltd., Stockley Park, UK.
Brian StwalleyUS Medical Affairs, Gilead Sciences, Inc., Foster City, CA, USA.
Michael StokesData Analytics, Evidera, Bethesda, MD, USA.
Aliki TaylorReal-World Evidence, Gilead Sciences Europe Ltd., Stockley Park, UK.
Rita NandaDepartment of Medicine, The University of Chicago Medicine, Chicago, IL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePatients with metastatic triple-negative breast cancer (mTNBC) have poor prognosis and limited treatment options. Sacituzumab govitecan (SG), a Trop-2-directed antibody-drug conjugate, is approved for patients with mTNBC who have received ≥ 2 systemic therapies (≥ 1 in the metastatic setting) based on the ASCENT study (NCT02574455). The current study describes real-world SG use and outcomes in patients with mTNBC in the United States.

methodsThis retrospective, observational study included adult patients with mTNBC from the ConcertAI Patient360™ database who received SG in the second line (2L) and later from April 2020 to May 2022. SG use patterns, effectiveness, and tolerability are described.

resultsThis analysis included 230 patients (median age 60 years, 26% Black, 17% with ECOG performance status ≥ 2, 66% in community settings; median of 2 prior lines of treatment in the metastatic setting); median follow-up was 7.2 months. Median (95% CI) real-world overall survival was 10.0 (8.3-11.1) months for all patients and 13.9 (9.8-not estimable) months in the 2L subgroup (n = 77). Granulocyte-colony stimulating factor (G-CSF) was administered concomitantly with SG in 134 (58%) patients; 35 (15%) received G-CSF for the first time. Median (IQR) time from SG start to G-CSF use was 8.5 (8.0-29.0) days. Seventeen (7%) patients discontinued SG due to toxicity.

conclusionsUsing a real-world, ethnically diverse population of patients with mTNBC presenting with poor prognosis, these data reinforced the findings from ASCENT. In routine clinical practice, SG is an effective treatment in the 2L setting, consistent with treatment guidelines.

Indexed as

Antibodies, Monoclonal, HumanizedCamptothecinImmunoconjugatesTriple Negative Breast NeoplasmsAdultAgedAged, 80 and overFemaleHumansMiddle AgedNeoplasm MetastasisRetrospective StudiesTreatment OutcomeUnited StatesAntibodies, Monoclonal, HumanizedCamptothecinImmunoconjugatessacituzumab govitecanMetastaticReal-world clinical outcomesSacituzumab govitecanSecond-lineTreatment patternsTriple-negative breast cancer

Identifiers

PMID38904892
PMCPMC11452463

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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.