Evidence map›Paper›PMID 41820395›Full record

Trial reportNature communications2026

ctDNA and tumor-based biomarkers of giredestrant response in acelERA breast cancer.

Ann E Collier, Stephanie Hilz, Alejandro M Chibly, Chunzhe Duan, Lincoln W Pasquina, Xiaopeng Sun, Mariana Chavez-MacGregor, Aditya Bardia, Miguel Martín, Elgene Lim and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2026. 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. Not yet cited in PubMed.

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

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

14 authors.

Ann E CollierGenentech, Inc., South San Francisco, CA, USA. collier.annie@gene.com.ORCID http://orcid.org/0000-0003-3410-3238
Stephanie HilzGenentech, Inc., South San Francisco, CA, USA.
Alejandro M ChiblyGenentech, Inc., South San Francisco, CA, USA.ORCID http://orcid.org/0000-0001-7747-4990
Chunzhe DuanRoche (China) Holding Ltd., Shanghai, China.
Lincoln W PasquinaFoundation Medicine Inc., Boston, MA, USA.ORCID http://orcid.org/0009-0009-5461-9777
Xiaopeng SunGenentech, Inc., South San Francisco, CA, USA.
Mariana Chavez-MacGregorThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0002-7189-0763
Aditya BardiaUniversity of California, Los Angeles, CA, USA.ORCID http://orcid.org/0000-0003-4885-1157
Miguel MartínHospital Gregorio Marañón, Universidad Complutense, GEICAM, CIBERONC, Madrid, Spain.ORCID http://orcid.org/0000-0001-9237-3231
Elgene LimGarvan Institute of Medical Research, St Vincent's Clinical School, University of New South Wales, Darlinghurst, Australia.ORCID http://orcid.org/0000-0001-8065-8838
Joohyuk SohnDivision of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.ORCID http://orcid.org/0000-0002-2303-2764
Pablo Diego Pérez-MorenoGenentech, Inc., South San Francisco, CA, USA.
Tharu M FernandoGenentech, Inc., South San Francisco, CA, USA.ORCID http://orcid.org/0000-0001-9672-6428
Heather M MooreGenentech, Inc., South San Francisco, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Endocrine therapy (ET) resistance in estrogen receptor positive (ER+) advanced breast cancer is often linked to ESR1 mutations, yet responses to oral selective ER degraders vary within mutant subgroups. Through a biomarker analysis of acelERA Breast Cancer (NCT04576455), we show that tumor ER transcriptional activity as well as circulating tumor DNA (ctDNA) genomics and dynamics effectively stratify response to ET, including giredestrant. We find that following first-line therapy, the ctDNA genomic landscape is diverse and influenced by CDK4/6 inhibitor exposure. Despite this complexity, ER activity in ESR1-mutant tumors remains comparable to early breast cancer but is reduced in most non-mutant cases. This maintained ER activity is associated with giredestrant benefit. Furthermore, early ctDNA clearance identifies responding patients, and the combination of low ER activity and high ctDNA burden predicts rapid clinical progression. These findings provide a framework for personalizing future breast cancer therapies by integrating liquid biopsies with tissue-based signatures.

Indexed as

Biomarkers, TumorBreast NeoplasmsCirculating Tumor DNAAntineoplastic Agents, HormonalDrug Resistance, NeoplasmEstrogen Receptor alphaFemaleHumansMutationAntineoplastic Agents, HormonalBiomarkers, TumorCirculating Tumor DNAESR1 protein, humanEstrogen Receptor alpha

Identifiers

PMID41820395
PMCPMC13121440

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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.