Evidence map›Paper›PMID 33769862›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies.

Aleix Prat, Anwesha Chaudhury, Nadia Solovieff, Laia Paré, Débora Martinez, Nuria Chic, Olga Martínez-Sáez, Fara Brasó-Maristany, Agnes Lteif, Tetiana Taran and 2 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. 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 trial NCT07617025 (Prognostic and Predictive Role of Intrinsic Molecular Subtypes in BRCA-associated Breast Cancer), which is not on this map. Cited by 99 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
99citing papers in PubMed, 6 pooled it
18.5field-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.

NCT07617025 recruitingnot on this mapstarted 2024, after this paper: background citation

Prognostic and Predictive Role of Intrinsic Molecular Subtypes in BRCA-associated Breast Cancer

TypeobservationalSponsorAngela TossRan2024 to 2026Enrolled100ConditionsBreast Cancer
3 · Its place in the literature

Who cites it

99 citing papers in PubMed, 6 syntheses or guidelines pooled it, 149 citations in OpenAlex.

  1. Pooled it
  2. Guideline
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  7. Trial
  8. 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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  14. 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
  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
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  17. 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
  18. Review
  19. Review
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 3 countries.

Aleix PratDepartment of Medical Oncology, Hospital Clínic of Barcelona, Barcelona, Spain.ORCID 0000-0001-8686-0236
Anwesha ChaudhuryNovartis Institutes for BioMedical Research, Cambridge, MA.ORCID 0000-0002-9945-6862
Nadia SolovieffNovartis Institutes for BioMedical Research, Cambridge, MA.
Laia ParéSOLTI Breast Cancer Research Group, Barcelona, Spain.ORCID 0000-0002-4904-558X
Débora MartinezSOLTI Breast Cancer Research Group, Barcelona, Spain.
Nuria ChicDepartment of Medical Oncology, Hospital Clínic of Barcelona, Barcelona, Spain.
Olga Martínez-SáezDepartment of Medical Oncology, Hospital Clínic of Barcelona, Barcelona, Spain.
Fara Brasó-MaristanyDepartment of Medical Oncology, Hospital Clínic of Barcelona, Barcelona, Spain.ORCID 0000-0001-5440-9643
Agnes LteifNovartis Pharmaceuticals Corporation, East Hanover, NJ.
Tetiana TaranNovartis Pharma AG, Basel, Switzerland.
Naveen BabbarNovartis Pharmaceuticals Corporation, East Hanover, NJ.
Fei SuNovartis Pharmaceuticals Corporation, East Hanover, NJ.
Hospital Clínic de Barcelona · ESConsorci Institut D'Investigacions Biomediques August Pi I Sunyer · ESNovartis (United States) · USInstituto Oncológico Dr. Rosell · ESNovartis (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe prognostic and predictive value of intrinsic subtypes in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with endocrine therapy and ribociclib (RIB) is currently unknown. We evaluated the association of intrinsic subtypes with progression-free survival (PFS) in the MONALEESA trials.

methodsA retrospective and exploratory PAM50-based analysis of tumor samples from the phase III MONALEESA-2, MONALEESA-3, and MONALEESA-7 trials was undertaken. The prognostic relationship of PAM50-based subtypes with PFS and risk of disease progression by subtype and treatment were evaluated using a multivariable Cox proportional hazards model, adjusting for age, prior chemotherapy, performance status, visceral disease, bone-only metastases, histological grade, number of metastatic sites, prior endocrine therapy, and de novo metastatic disease.

resultsOverall, 1,160 tumors from the RIB (n = 672) and placebo (n = 488) cohorts were robustly profiled. Subtype distribution was luminal A (LumA), 46.7%; luminal B (LumB), 24.0%; normal-like, 14.0%; HER2-enriched (HER2E), 12.7%; and basal-like, 2.6% and was generally consistent across treatment arms and trials. The associations between subtypes and PFS were statistically significant in both arms (

conclusionIn this retrospective exploratory analysis of hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer, each intrinsic subtype exhibited a consistent PFS benefit with RIB, except for basal-like.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBone NeoplasmsBreast NeoplasmsDouble-Blind MethodErb-b2 Receptor Tyrosine KinasesFemaleFollow-Up StudiesHumansPrognosisReceptors, EstrogenReceptors, ProgesteroneRetrospective StudiesSurvival RateBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesReceptors, EstrogenReceptors, Progesterone

Identifiers

PMID33769862
PMCPMC8196091
OpenAlexW3136964832

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

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.