Evidence map›Paper›PMID 35552673›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2022

Overall Survival with Palbociclib and Fulvestrant in Women with HR+/HER2- ABC: Updated Exploratory Analyses of PALOMA-3, a Double-blind, Phase III Randomized Study.

Massimo Cristofanilli, Hope S Rugo, Seock-Ah Im, Dennis J Slamon, Nadia Harbeck, Igor Bondarenko, Norikazu Masuda, Marco Colleoni, Angela DeMichele, Sherene Loi and 10 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 140 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
140citing papers in PubMed, 9 pooled it
27.2field-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

140 citing papers in PubMed, 9 syntheses or guidelines pooled it, 189 citations in OpenAlex.

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  6. Guideline
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  10. Pembrolizumab and Paclitaxel in Patients with HR+/HER2- Breast Cancer with HER2-Enriched or Basal-like Subtypes.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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80 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

20 authors at 16 institutions in 9 countries.

Massimo CristofanilliWeill Cornell Medicine, New York, New York.ORCID 0000-0002-4194-7175
Hope S RugoUniversity of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California.
Seock-Ah ImSeoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of South Korea.ORCID 0000-0002-5396-6533
Dennis J SlamonDavid Geffen School of Medicine at University of California Los Angeles, Santa Monica, California.
Nadia HarbeckBrustzentrum, Frauenklinik and CCC Munich, LMU University Hospital, Munich, Germany.ORCID 0000-0002-9744-7372
Igor BondarenkoDnipropetrovsk Medical Academy, City Multiple-Discipline Clinical Hospital #4, Dnipropetrovsk, Ukraine.ORCID 0000-0002-7071-2471
Norikazu MasudaNagoya University Graduate School of Medicine, Showa-ku, Nagoya, Japan.ORCID 0000-0002-7302-0278
Marco ColleoniIEO, Istituto Europeo di Oncologia, IRCCS, Milan, Italy.ORCID 0000-0002-5743-3013
Angela DeMicheleAbramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.
Sherene LoiPeter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia.ORCID 0000-0001-6137-9171
Hiroji IwataAichi Cancer Center Hospital, Chikusa-ku, Nagoya, Japan.ORCID 0000-0002-0242-4718
Ben O'LearyRoyal Marsden Hospital and Institute of Cancer Research, London, United Kingdom.ORCID 0000-0002-1092-9169
Fabrice AndréInstitut Gustave Roussy, Villejuif, France.ORCID 0000-0001-5795-8357
Sibylle LoiblGerman Breast Group, Neu-Isenburg, Germany.ORCID 0000-0001-6488-4958
Eustratios BananisPfizer Inc, New York, New York.
Yuan LiuPfizer Inc, San Diego, California.
Xin HuangPfizer Inc, San Diego, California.ORCID 0000-0003-3285-365X
Sindy KimPfizer Inc, San Diego, California.
Maria Jose Lechuga FreanPfizer Inc, San Diego, California.
Nicholas C TurnerRoyal Marsden Hospital and Institute of Cancer Research, London, United Kingdom.
Kratos Defense & Security Solutions (United States) · USInstitute of Cancer Research · GBAichi Cancer Center · JPCornell University · USDnipro State Medical University · UAEuropean Institute of Oncology · ITFrauenklinik der Technischen Universität München · DEGerman Breast group · DEInstitut Gustave Roussy · FRPeter MacCallum Cancer Centre · AUSeoul National University Hospital · KRShowa University · JPThe Fertilizer Institute · USUCSF Helen Diller Family Comprehensive Cancer Center · USUniversity of California System · USUniversity of Pennsylvania · US

Funding

Medical Research Council MR/N002121/1
6 · The paper itself

Abstract

purposeTo conduct an updated exploratory analysis of overall survival (OS) with a longer median follow-up of 73.3 months and evaluate the prognostic value of molecular analysis by circulating tumor DNA (ctDNA). PATIENTS AND

methodsPatients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) were randomized 2:1 to receive palbociclib (125 mg orally/day; 3/1 week schedule) and fulvestrant (500 mg intramuscularly) or placebo and fulvestrant. This OS analysis was performed when 75% of enrolled patients died (393 events in 521 randomized patients). ctDNA analysis was performed among patients who provided consent.

resultsAt the data cutoff (August 17, 2020), 258 and 135 deaths occurred in the palbociclib and placebo groups, respectively. The median OS [95% confidence interval (CI)] was 34.8 months (28.8-39.9) in the palbociclib group and 28.0 months (23.5-33.8) in the placebo group (stratified hazard ratio, 0.81; 95% CI, 0.65-0.99). The 6-year OS rate (95% CI) was 19.1% (14.9-23.7) and 12.9% (8.0-19.1) in the palbociclib and placebo groups, respectively. Favorable OS with palbociclib plus fulvestrant compared with placebo plus fulvestrant was observed in most subgroups, particularly in patients with endocrine-sensitive disease, no prior chemotherapy for ABC and low circulating tumor fraction and regardless of ESR1, PIK3CA, or TP53 mutation status. No new safety signals were identified.

conclusionsThe clinically meaningful improvement in OS associated with palbociclib plus fulvestrant was maintained with >6 years of follow-up in patients with HR+/HER2- ABC, supporting palbociclib plus fulvestrant as a standard of care in these patients.

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesAntineoplastic Combined Chemotherapy ProtocolsDouble-Blind MethodFemaleFulvestrantHumansPiperazinesPyridinesErb-b2 Receptor Tyrosine KinasesFulvestrantpalbociclibPiperazinesPyridines

Identifiers

PMID35552673
PMCPMC9662922
OpenAlexW4280523559

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.