Evidence map›Paper›PMID 30807234›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Cyclin E1 Expression and Palbociclib Efficacy in Previously Treated Hormone Receptor-Positive Metastatic Breast Cancer.

Nicholas C Turner, Yuan Liu, Zhou Zhu, Sherene Loi, Marco Colleoni, Sibylle Loibl, Angela DeMichele, Nadia Harbeck, Fabrice André, Mohamed Amine Bayar and 6 more

Erratum issued 2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. 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 2 registered trials, which are not on this map. Cited by 278 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
278citing papers in PubMed, 6 pooled it
33.8field-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.

NCT01942135 phase3completednot on this map

Multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of fulvestrant (faslodex (registered)). with or without pd-0332991 (palbociclib) +/- goserelin in women with hormone receptor-positive, her2-negative metastatic breast cancer whose disease progressed after prior endocrine therapy

TypeinterventionalSponsorPfizerRan2013 to 2022Enrolled521ConditionsMetastatic Breast CancerArmsPalbociclib, Fulvestrant, Placebo
NCT02008734 phase2completednot on this map

Randomized Short-term Pre-surgical Study to Assess the Effects of PD 0332991 in Early Breast Cancer Patients

TypeinterventionalSponsorGustave Roussy, Cancer Campus, Grand ParisRan2014 to 2016Enrolled132ConditionsUntreated Operable Early Breast CancerArmsPD0332991
3 · Its place in the literature

Who cites it

278 citing papers in PubMed, 6 syntheses or guidelines pooled it, 445 citations in OpenAlex.

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  13. CCNE1 and PLK1 Mediate Resistance to Palbociclib in HR+/HER2- Metastatic Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Trial
  14. Phase II Study of Palbociclib (PD-0332991) in CCND1, 2, or 3 Amplification: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol Z1B.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Trial
  15. Palbociclib Rechallenge for Hormone Receptor-Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Trial
  16. Biomarkers of Response and Resistance to Palbociclib Plus Letrozole in Patients With ERClinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Trial
  17. Next-generation CDK inhibitors in HR+/HER2- breast cancer.The Journal of clinical investigation · 2026
    Review
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  19. Article
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218 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 10 institutions in 6 countries.

Nicholas C Turner1 Royal Marsden Hospital and Institute of Cancer Research, London, United Kingdom.
Yuan Liu2 Pfizer, La Jolla, CA.
Zhou Zhu2 Pfizer, La Jolla, CA.
Sherene Loi3 Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia.
Marco Colleoni4 Istituto Europeo di Oncologia, Milan, Italy.
Sibylle Loibl5 German Breast Group, Neu-Isenburg, Germany.
Angela DeMichele6 University of Pennsylvania, Philadelphia, PA.
Nadia Harbeck7 Ludwig Maximilian University of Munich, Munich, Germany.
Fabrice André8 Institut Gustave Roussy, Villejuif, France.
Mohamed Amine Bayar8 Institut Gustave Roussy, Villejuif, France.
Stefan Michiels8 Institut Gustave Roussy, Villejuif, France.
Zhe Zhang2 Pfizer, La Jolla, CA.
Carla Giorgetti9 Pfizer, Milan, Italy.
Monica Arnedos8 Institut Gustave Roussy, Villejuif, France.
Cynthia Huang Bartlett10 Pfizer, New York, NY.
Massimo Cristofanilli11 Robert H Lurie Comprehensive Cancer Center, Chicago, IL.
Institut Gustave Roussy · FRPfizer (United States) · USGerman Breast group · DEInstitute of Cancer Research · GBIstituti di Ricovero e Cura a Carattere Scientifico · ITLudwig-Maximilians-Universität München · DEPeter MacCallum Cancer Centre · AUPfizer (Italy) · ITRobert H. Lurie Comprehensive Cancer Center of Northwestern UniversityUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeA large-panel gene expression analysis was conducted to identify biomarkers associated with the effectiveness of adding palbociclib to fulvestrant.

methodsThe PALOMA-3 ( ClinicalTrials.gov identifier: NCT01942135) trial randomly assigned 521 endocrine-pretreated patients with metastatic breast cancer to receive palbociclib plus fulvestrant or placebo plus fulvestrant. Primary analysis was first conducted on 10 genes on the basis of pathway biology and evidence from previous studies followed by a systematic panel-wide search among 2,534 cancer-related genes. The association of gene expression with the effect of palbociclib on progression-free survival (PFS) was evaluated using Cox proportional hazards regression analysis, with gene expression as a continuous variable or dichotomized by median. An independent breast cancer cohort from the Preoperative Palbociclib (POP) Clinical Trial ( ClinicalTrials.gov identifier: NCT02008734) was used for validation, in 61 patients with primary breast cancer treated with 2 weeks of palbociclib.

resultsIn the PALOMA-3 trial, 302 patients had tumor tissue analyzed (palbociclib arm, 194 patients; placebo arm, 108 patients). Palbociclib efficacy was lower in patients with high versus low cyclin E1 (

conclusionAddition of palbociclib to fulvestrant demonstrated efficacy in all biomarker groups, although high

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCyclin EFemaleFulvestrantGene Expression ProfilingHumansNeoplasm MetastasisOncogene ProteinsPiperazinesProgression-Free SurvivalProportional Hazards ModelsPyridinesReceptors, EstrogenReceptors, ProgesteroneBiomarkers, TumorCCNE1 protein, humanCyclin EFulvestrantOncogene ProteinspalbociclibPiperazinesPyridinesReceptors, EstrogenReceptors, ProgesteroneRNA, Messenger

Identifiers

PMID30807234
PMCPMC6506420
OpenAlexW2917464640

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.