Evidence map›Paper›PMID 38664404›Full record

ArticleNPJ breast cancer2024

Subgroup analyses from the phase 3 ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer.

Sara A Hurvitz, Aditya Bardia, Kevin Punie, Kevin Kalinsky, Lisa A Carey, Hope S Rugo, Véronique Diéras, See Phan, Rosemary Delaney, Yanni Zhu and 1 more

Erratum issued Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in NPJ breast cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. 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 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
11.3field-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.

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

40 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 3 countries.

Sara A HurvitzClinical Research Division, Department of Medicine, UW Medicine, Fred Hutchinson Cancer Center, Seattle, WA, USA. shurvitz@fredhutch.org.ORCID http://orcid.org/0000-0001-7808-7191
Aditya BardiaMassachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.
Kevin PunieDepartment of General Medical Oncology and Multidisciplinary Breast Centre, Leuven Cancer Institute and University Hospitals Leuven, Leuven, Belgium.
Kevin KalinskyWinship Cancer Institute, Emory University, Atlanta, GA, USA.ORCID http://orcid.org/0000-0002-3113-7902
Lisa A CareyUniversity of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.ORCID http://orcid.org/0000-0003-2388-4649
Hope S RugoUniversity of California San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.ORCID http://orcid.org/0000-0001-6710-4814
Véronique DiérasCentre Eugène Marquis, Rennes, France.ORCID http://orcid.org/0000-0001-8094-4738
See PhanGilead Sciences Inc., Foster City, CA, USA.
Rosemary DelaneyGilead Sciences Inc., Foster City, CA, USA.
Yanni ZhuGilead Sciences Inc., Foster City, CA, USA.
Sara M TolaneyDana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.ORCID http://orcid.org/0000-0002-5940-8671
Gilead Sciences (United States) · USHarvard University · USCentre Eugène Marquis · FREmory University · USFred Hutch Cancer Center · USKU Leuven · BEUniversity of California, San Francisco · USUniversity of North Carolina at Chapel Hill · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In this post hoc analysis of the ASCENT study, we compared outcomes with sacituzumab govitecan (SG) vs single-agent chemotherapy in clinically important subgroups of patients with metastatic triple-negative breast cancer (mTNBC). Patients with mTNBC refractory to/relapsing after ≥2 prior chemotherapies (≥1 in the metastatic setting) were randomized 1:1 to receive SG or treatment of physician's choice (TPC) until unacceptable toxicity/progression. The primary endpoint was progression-free survival (PFS) per RECIST 1.1 by central review in patients without brain metastases. Patients with brain metastases were allowed if metastases were stable ≥4 weeks. In the intention-to-treat (ITT) population, 19% of patients were age ≥65 years; 12% were Black, and 12% had brain metastases. SG improved PFS and overall survival (OS), respectively, vs TPC in patients age ≥65 years (7.1 vs 2.4 months and 14.7 vs 8.9 months), or of Black race (5.4 vs 2.2 months and 13.8 vs 8.5 months), consistent with outcomes in the ITT population. Patients with brain metastases had numerically higher median PFS with SG vs TPC, but median OS was similar between treatment groups. SG was well tolerated and had a manageable safety profile consistent with the full safety population across all subgroups; neutropenia and diarrhea were the most common treatment-emergent adverse events. These findings confirm the meaningful clinical benefit of SG vs standard chemotherapy in patient subgroups with high unmet needs. SG should be considered an effective and safe treatment option for patients with mTNBC eligible for second-line or later therapy. ClinicalTrials.gov Number: NCT02574455.

Identifiers

PMID38664404
PMCPMC11045722
OpenAlexW4395467344

What Socratic holds

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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 Socratic graph.