Evidence map›Paper›PMID 35545724›Full record

Trial reportBreast cancer research and treatment2022

Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer.

Joyce O'Shaughnessy, Adam Brufsky, Hope S Rugo, Sara M Tolaney, Kevin Punie, Sagar Sardesai, Erika Hamilton, Delphine Loirat, Tiffany Traina, Roberto Leon-Ferre and 8 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2022. 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 32 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 3 pooled it
5.6field-weighted citation impact, top 3% 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.

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

32 citing papers in PubMed, 3 syntheses or guidelines pooled it, 41 citations in OpenAlex.

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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

18 authors at 17 institutions in 4 countries.

Joyce O'ShaughnessyMedical Oncology, Texas Oncology-Baylor Charles A. Sammons Cancer Center, 3410 Worth St., Suite 400, Dallas, TX, 75246, USA. joyce.oshaughnessy@usoncology.com.ORCID http://orcid.org/0000-0001-6764-2807
Adam BrufskyMagee-Womens Hospital and the Hillman Cancer Center, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Hope S RugoDepartment of Medicine, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.
Sara M TolaneyMedical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Kevin PunieDepartment of General Medical Oncology and Multidisciplinary Breast Centre, Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium.
Sagar SardesaiThe Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.
Erika HamiltonSarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA.
Delphine LoiratMedical Oncology Department and D3i, Institut Curie, Paris, France.
Tiffany TrainaMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Roberto Leon-FerreDepartment of Oncology, Mayo Clinic, Rochester, MN, USA.
Sara A HurvitzMedical Oncology, University of California, Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.
Kevin KalinskyColumbia University Irving Medical Center, New York, NY, USA.
Aditya BardiaDepartment of Hematology/Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, USA.
Stephanie HenryDepartment of Oncology-Hematology, Radiotherapy, and Nuclear Medicine, CHU UCL Namur, Namur, Belgium.
Ingrid MayerBreast Cancer Program, Division of Hematology/Oncology, Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.
Yanni ZhuDepartment of Biostatistics, Gilead Sciences, Inc., Foster City, CA, USA.
See PhanDepartment of Clinical Development, Gilead Sciences, Inc., Foster City, CA, USA.
Javier CortésInternational Breast Cancer Center, Quironsalud Group, Barcelona, Spain.
Gilead Sciences (United States) · USBreast Cancer Research Foundation · USCHU Dinant Godinne UCL Namur · BEDana-Farber Cancer Institute · USEmory University · USHarvard University · USHospital Quirónsalud Barcelona · ESInstitut Curie · FRKU Leuven · BEMagee-Womens Hospital · USMayo Clinic in Arizona · USMemorial Sloan Kettering Cancer Center · USSarah Cannon · USTexas Oncology · USThe Ohio State University · USUniversity of California, Los Angeles · USUniversity of California, San Francisco · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI AKHILESH PANDEY · 1985 to 2026
$151.3M
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA015083
6 · The paper itself

Abstract

purposeSacituzumab govitecan (SG) is an antibody-drug conjugate composed of an anti-Trop-2 antibody coupled to SN-38 via a proprietary hydrolyzable linker. In the ASCENT study, SG improved survival versus single-agent treatment of physician's choice (TPC) in pre-treated metastatic triple-negative breast cancer (mTNBC). Hormone/HER2 receptor changes are common, particularly at relapse/metastasis. This subanalysis assessed outcomes in patients who did/did not have TNBC at initial diagnosis, before enrollment.

methodsTNBC diagnosis was only required at study entry. Patients with mTNBC refractory/relapsing after ≥ 2 prior chemotherapies were randomized 1:1 to receive SG or TPC. Primary endpoint was progression-free survival (PFS) in patients without brain metastases.

resultsOverall, 70/235 (30%) and 76/233 (33%) patients who received SG and TPC, respectively, did not have TNBC at initial diagnosis. Clinical benefit with SG versus TPC was observed in this subset. Median PFS was 4.6 versus 2.3 months (HR 0.48; 95% CI 0.32-0.72), median overall survival was 12.4 versus 6.7 months (HR 0.44; 95% CI 0.30-0.64), and objective response rate (ORR) was 31% versus 4%; those who also received prior CDK4/6 inhibitors had ORRs of 21% versus 5%. Efficacy and safety for patients with TNBC at initial diagnosis were generally similar to those who did not present with TNBC at initial diagnosis.

conclusionPatients without TNBC at initial diagnosis had improved clinical outcomes and a manageable safety profile with SG, supporting SG as a treatment option for mTNBC regardless of subtype at initial diagnosis. Subtype reassessment in advanced breast cancer allows for optimal treatment. Clinical trial registration number NCT02574455, registered October 12, 2015.

Indexed as

Breast NeoplasmsImmunoconjugatesTriple Negative Breast NeoplasmsAntibodies, Monoclonal, HumanizedCamptothecinFemaleHumansNeoplasm Recurrence, LocalAntibodies, Monoclonal, HumanizedCamptothecinImmunoconjugatessacituzumab govitecanAntibody–drug conjugateCyclin-dependent kinase inhibitorSacituzumab govitecan

Identifiers

PMID35545724
PMCPMC9374646
OpenAlexW4280552798

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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.