Evidence map›Paper›PMID 38748596›Full record

Trial reportThe oncologist2024

Health-related quality of life with sacituzumab govitecan in HR+/HER2- metastatic breast cancer in the phase III TROPiCS-02 trial.

Hope S Rugo, Peter Schmid, Sara M Tolaney, Florence Dalenc, Frederik Marmé, Ling Shi, Wendy Verret, Anuj Shah, Mahdi Gharaibeh, Aditya Bardia and 1 more

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in The oncologist, 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 NCT03901339 (Phase 3 Study of Sacituzumab Govitecan), which is not on this map. Cited by 16 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 4 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.

NCT03901339 phase3completednot on this map

Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Least Two Prior Chemotherapy Regimens

TypeinterventionalSponsorGilead SciencesRan2019 to 2023Enrolled543ConditionsMetastatic Breast CancerArmsSacituzumab Govitecan-hziy, Eribulin, Capecitabine, Gemcitabine, Vinorelbine
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  7. Cancers · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Hope S RugoDepartment of Medicine, University of California-San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, United States.ORCID 0000-0001-6710-4814
Peter SchmidBarts Cancer Institute, Queen Mary University of London, London, United Kingdom.
Sara M TolaneyDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.
Florence DalencInstitut Claudius Régaud, Toulouse, France.
Frederik MarméMedical Faculty Mannheim, Heidelberg University, University Hospital Mannheim, Heidelberg, Germany.ORCID 0000-0002-6591-3367
Ling ShiDepartment of Evidence Synthesis, Modeling and Communication, Evidera Inc., Bethesda, MD, United States.
Wendy VerretDepartment of Clinical Development, Gilead Sciences, Inc., Foster City, CA, United States.
Anuj ShahDepartment of Health Economics and Outcomes Research, Gilead Sciences, Inc., Foster City, CA, United States.
Mahdi GharaibehDepartment of Health Economics and Outcomes Research, Gilead Sciences, Inc., Foster City, CA, United States.
Aditya BardiaMedical Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, United States.
Javier CortesOncology Department, International Breast Cancer Center (IBCC), Pangaea Oncology, Quiron Group, Barcelona, Spain.

Funding

Gilead Sciences
6 · The paper itself

Abstract

backgroundThe TROPiCS-02 study (NCT03901339) demonstrated that sacituzumab govitecan (SG) has superior clinical outcomes over treatment of physician's choice (TPC) chemotherapy in patients with hormone receptor-positive, human epidermal growth factor 2 receptor-negative (HR+/HER2-) metastatic breast cancer (mBC). Here, we present health-related quality of life (HRQoL) patient-reported outcome (PRO) findings from this study. PATIENTS AND

methodsEligible adults with HR+/HER2- mBC who previously received a taxane, endocrine-based therapy, a CDK4/6 inhibitor, and 2-4 lines of chemotherapy were randomized 1:1 to receive SG or TPC until progression or unacceptable toxicity. PROs were assessed at baseline and on day 1 of each cycle, using the European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 (EORTC QLQ-C30), EQ-5D-5L, and PRO Common Terminology Criteria for Adverse Events (PRO-CTCAE).

resultsCompared to TPC, overall least square mean change from baseline was significantly better for SG for physical functioning and dyspnea, but worse for diarrhea. Time to first clinically meaningful worsening or death was significantly longer for SG in global health status/quality of life, physical functioning, fatigue, emotional functioning, dyspnea, insomnia, and financial difficulties of the EORTC QLQ-C30 and the EQ-VAS, but longer for TPC in diarrhea. Few patients in both arms reported experiencing any worsening to level 3 or 4 treatment-related symptomatic events during treatment, as assessed by 16 PRO-CTCAE items, except for diarrhea frequency and amount of hair loss, which favored TPC.

conclusionsSG was associated with an HRQoL benefit in most symptoms and functioning, compared with TPC. This supports the favorable profile of SG as a treatment option for patients with pretreated HR+/HER2- mBC.

Indexed as

Antibodies, Monoclonal, HumanizedBreast NeoplasmsCamptothecinErb-b2 Receptor Tyrosine KinasesQuality of LifeAdultAgedFemaleHumansImmunoconjugatesMiddle AgedNeoplasm MetastasisReceptors, ProgesteroneAntibodies, Monoclonal, HumanizedCamptothecinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoconjugatesReceptors, Progesteronesacituzumab govitecanantibody–drug conjugateEORTC QLQ-C30HR+/HER2−metastatic breast cancerphase IIIquality of lifeSacituzumab govitecan

Identifiers

PMID38748596
PMCPMC11379636

What OpenQuestion 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 OpenQuestion graph.