Evidence map›Paper›PMID 38537155›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Giredestrant for Estrogen Receptor-Positive, HER2-Negative, Previously Treated Advanced Breast Cancer: Results From the Randomized, Phase II acelERA Breast Cancer Study.

Miguel Martín, Elgene Lim, Mariana Chavez-MacGregor, Aditya Bardia, Jiong Wu, Qingyuan Zhang, Zbigniew Nowecki, Felipe Melo Cruz, Rustem Safin, Sung-Bae Kim and 12 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04576455 (A Phase II, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Compared With Physician's Choice of Endocrine Monotherapy in Patients With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer), which is not on this map. Cited by 44 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 3 pooled it
22.6field-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.

NCT04576455 phase2active not recruitingnot on this map

A Phase II, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Compared With Physician's Choice of Endocrine Monotherapy in Patients With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

TypeinterventionalSponsorHoffmann-La RocheRan2020 to 2027Enrolled303ConditionsEstrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast CancerArmsGiredestrant, Fulvestrant or an Aromatase Inhibitor (Physician Choice), LHRH Agonist
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 3 syntheses or guidelines pooled it, 54 citations in OpenAlex.

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  6. Current oncology (Toronto, Ont.) · 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

22 authors at 15 institutions in 11 countries.

Miguel MartínHospital Gregorio Marañón, Universidad Complutense, GEICAM, CIBERONC, Madrid, Spain.ORCID 0000-0001-9237-3231
Elgene LimGarvan Institute of Medical Research, St Vincent's Clinical School, University of New South Wales, Darlinghurst, Australia.ORCID 0000-0001-8065-8838
Mariana Chavez-MacGregorThe University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-7189-0763
Aditya BardiaMassachusetts General Hospital, Harvard Medical School, Boston, MA.ORCID 0000-0003-4885-1157
Jiong WuFudan University Cancer Institute, Shanghai, China.ORCID 0000-0002-8103-0505
Qingyuan ZhangHarbin Medical University Cancer Hospital, Harbin, China.
Zbigniew NoweckiMaria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland.ORCID 0000-0001-7706-8191
Felipe Melo CruzNúcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo, Brazil.ORCID 0000-0002-4558-4850
Rustem SafinRepublican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan, Kazan, Russian Federation.ORCID 0000-0003-0585-7727
Sung-Bae KimAsan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.ORCID 0000-0001-5588-8332
Christian SchemKrankenhaus Jerusalem, Mammazentrum Hamburg, Hamburg, Germany.
Alberto J MonteroUniversity Hospitals/Seidman Cancer Center, Case Western Reserve University, Cleveland, OH.ORCID 0000-0002-8221-8120
Sarah KhanNottingham University Hospitals, City Hospital Campus, Nottingham, United Kingdom.
Reeti BandyopadhyayGenentech, Inc, South San Francisco, CA.
Heather M MooreGenentech, Inc, South San Francisco, CA.ORCID 0000-0002-7098-3888
Mahesh ShivhareRoche Products Limited, Welwyn Garden City, United Kingdom.
Monika PatreF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Jorge MartinalboF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Laura RoncoroniF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Pablo Diego Pérez-MorenoGenentech, Inc, South San Francisco, CA.
Joohyuk SohnYonsei University College of Medicine, Seoul, Republic of Korea.ORCID 0000-0002-2303-2764
acelERA Breast Cancer Study Investigators
Yonsei University · KRRoche (Switzerland) · CHUlsan College · KRCentro Universitário São Camilo · BRMammazentrum Hamburg · DERepublican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan · RUFudan University Shanghai Cancer Center · CNHarbin Medical University · CNRoche (United Kingdom) · GBThe Maria Sklodowska-Curie National Research Institute of Oncology · PLUniversity Hospitals Seidman Cancer Center · USGarvan Institute of Medical Research · AUHarvard University · USHospital General Universitario Gregorio Marañón · ESThe University of Texas MD Anderson Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo compare giredestrant and physician's choice of endocrine monotherapy (PCET) for estrogen receptor-positive, HER2-negative, advanced breast cancer (BC) in the phase II acelERA BC study (ClinicalTrials.gov identifier: NCT04576455).

methodsPost-/pre-/perimenopausal women, or men, age 18 years or older with measurable disease/evaluable bone lesions, whose disease progressed after 1-2 lines of systemic therapy (≤1 targeted, ≤1 chemotherapy regimen, prior fulvestrant allowed) were randomly assigned 1:1 to giredestrant (30 mg oral once daily) or fulvestrant/aromatase inhibitor per local guidelines (+luteinizing hormone-releasing hormone agonist in pre-/perimenopausal women, and men) until disease progression/unacceptable toxicity. Stratification was by visceral versus nonvisceral disease, prior cyclin-dependent kinase 4/6 inhibitor, and prior fulvestrant. The primary end point was investigator-assessed progression-free survival (INV-PFS).

resultsAt clinical cutoff (February 18, 2022; median follow-up: 7.9 months; N = 303), the INV-PFS hazard ratio (HR) was 0.81 (95% CI, 0.60 to 1.10;

conclusionAlthough the acelERA BC study did not reach statistical significance for its primary INV-PFS end point, there was a consistent treatment effect with giredestrant across most key subgroups and a trend toward favorable benefit among patients with

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesFulvestrantReceptors, EstrogenAdultAgedAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsFemaleHumansMaleMiddle AgedProgression-Free SurvivalAntineoplastic Agents, HormonalAromatase InhibitorsERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesFulvestrantReceptors, Estrogen

Identifiers

PMID38537155
PMCPMC11185917
OpenAlexW4393216842

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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.