Evidence map›Paper›PMID 27174596›Full record

Trial reportNature communications2016

Heterogeneity and clinical significance of ESR1 mutations in ER-positive metastatic breast cancer patients receiving fulvestrant.

Jill M Spoerke, Steven Gendreau, Kimberly Walter, Jiaheng Qiu, Timothy R Wilson, Heidi Savage, Junko Aimi, Mika K Derynck, Meng Chen, Iris T Chan and 6 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 192 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
192citing papers in PubMed, 3 pooled it
33.6field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

192 citing papers in PubMed, 3 syntheses or guidelines pooled it, 292 citations in OpenAlex.

  1. Pooled it
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  7. Clinical Significance of PIK3CA and ESR1 Mutations in Circulating Tumor DNA: Analysis from the MONARCH 2 Study of Abemaciclib plus Fulvestrant.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Trial
  8. Trial
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  12. Observational
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  16. Current oncology (Toronto, Ont.) · 2026
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  17. Review
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  20. Clinical and Genomic Factors Associated with Elacestrant Outcomes in ESR1-Mutant Metastatic Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article

132 more citing papers are in PubMed but not listed here.

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

16 authors at 3 institutions in 2 countries.

Jill M SpoerkeGenentech, Inc, South San Francisco, California 94080, USA.
Steven GendreauGenentech, Inc, South San Francisco, California 94080, USA.
Kimberly WalterGenentech, Inc, South San Francisco, California 94080, USA.
Jiaheng QiuGenentech, Inc, South San Francisco, California 94080, USA.
Timothy R WilsonGenentech, Inc, South San Francisco, California 94080, USA.
Heidi SavageGenentech, Inc, South San Francisco, California 94080, USA.
Junko AimiGenentech, Inc, South San Francisco, California 94080, USA.
Mika K DerynckGenentech, Inc, South San Francisco, California 94080, USA.
Meng ChenGenentech, Inc, South San Francisco, California 94080, USA.
Iris T ChanGenentech, Inc, South San Francisco, California 94080, USA.
Lukas C AmlerGenentech, Inc, South San Francisco, California 94080, USA.
Garret M HamptonGenentech, Inc, South San Francisco, California 94080, USA.
Stephen JohnstonRoyal Marsden NHS Foundation Trust, London SW3 6JJ, UK.
Ian KropDana-Farber Cancer Institute, Boston, Massachusetts 02215, USA.
Peter SchmidBarts Cancer Institute, Queen Mary University London, London EC1M 6BQ, UK.
Mark R LacknerGenentech, Inc, South San Francisco, California 94080, USA.
Dana-Farber Cancer Institute · USQueen Mary University of London · GBRoyal Marsden NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Mutations in ESR1 have been associated with resistance to aromatase inhibitor (AI) therapy in patients with ER+ metastatic breast cancer. Little is known of the impact of these mutations in patients receiving selective oestrogen receptor degrader (SERD) therapy. In this study, hotspot mutations in ESR1 and PIK3CA from ctDNA were assayed in clinical trial samples from ER+ metastatic breast cancer patients randomized either to the SERD fulvestrant or fulvestrant plus a pan-PI3K inhibitor. ESR1 mutations are present in 37% of baseline samples and are enriched in patients with luminal A and PIK3CA-mutated tumours. ESR1 mutations are often polyclonal and longitudinal analysis shows distinct clones exhibiting divergent behaviour over time. ESR1 mutation allele frequency does not show a consistent pattern of increases during fulvestrant treatment, and progression-free survival is not different in patients with ESR1 mutations compared with wild-type patients. ESR1 mutations are not associated with clinical resistance to fulvestrant in this study.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBreastBreast NeoplasmsClass I Phosphatidylinositol 3-KinasesDisease-Free SurvivalDNA Mutational AnalysisDNA, NeoplasmDrug Resistance, NeoplasmEstradiolEstrogen Receptor alphaEstrogen Receptor AntagonistsEstrogensFemale2-(1H-indazol-4-yl)-6-(4-methanesulfonylpiperazin-1-ylmethyl)-4-morpholin-4-ylthieno(3,2-d)pyrimidineClass I Phosphatidylinositol 3-KinasesDNA, NeoplasmESR1 protein, humanEstradiolEstrogen Receptor alphaEstrogen Receptor AntagonistsEstrogensFulvestrantIndazolesPIK3CA protein, humanProtein Kinase InhibitorsSulfonamides

Identifiers

PMID27174596
PMCPMC4869259
OpenAlexW2374277491

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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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.