Evidence map›Paper›PMID 39656951›Full record

Trial reportJournal of the National Cancer Institute2025

Race and clinical outcomes in hormone receptor-positive, HER2-negative, node-positive breast cancer in the randomized RxPONDER trial.

Yara Abdou, William E Barlow, Julie R Gralow, Funda Meric-Bernstam, Kathy S Albain, Daniel F Hayes, Nancy U Lin, Edith A Perez, Lori J Goldstein, Stephen K L Chia and 14 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Journal of the National Cancer Institute, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01272037 (A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer With Recurrence Score), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–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.

NCT01272037 phase3active not recruitingnot on this map

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer With Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2011 to 2027Enrolled5,018ConditionsBreast Ductal Carcinoma In Situ, Invasive Breast Carcinoma, Multicentric Breast Carcinoma, Multifocal Breast CarcinomaArmsAnastrozole, Exemestane, Laboratory Biomarker Analysis, Letrozole, Quality-of-Life Assessment
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Article
  3. Article
  4. Article
  5. Article
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

24 authors.

Yara AbdouUniversity of North Carolina at Chapel Hill, Chapel Hill, NC, United States.ORCID 0000-0002-4827-8613
William E BarlowSWOG Statistics and Data Management Center, Seattle, WA, United States.ORCID 0000-0003-4651-2282
Julie R GralowAmerican Society of Clinical Oncology, Alexandria, VA, United States.
Funda Meric-BernstamThe University of Texas MD Anderson Cancer Center, Houston, TX, United States.ORCID 0000-0001-6816-6072
Kathy S AlbainLoyola University Medical Center, Maywood, IL, United States.
Daniel F HayesUniversity of Michigan, Ann Arbor, MI, United States.ORCID 0000-0003-3620-7575
Nancy U LinDana Farber Cancer Institute, Boston, MA, United States.ORCID 0000-0003-2263-5413
Edith A PerezMayo Clinic Jacksonville, Jacksonville, FL, United States.
Lori J GoldsteinFox Chase Cancer Center, Philadelphia, PA, United States.
Stephen K L ChiaBCCA-Vancouver Cancer Centre, Vancouver, BC, Canada.
Sukhbinder Dhesy-ThindMcMaster University, Hamilton, ON, Canada.ORCID 0000-0002-6377-4703
Priya RastogiUniversity of Pittsburgh School of Medicine, Pittsburgh, PA, United States.ORCID 0000-0002-6179-6407
Emilio AlbaVirgen de la Victoria University Hospitals of Málaga, Malago, Spain.ORCID 0000-0002-3364-2603
Suzette DelalogeInstitut Gustave Roussy, Paris, France.ORCID 0000-0003-2106-9165
Anne F SchottUniversity of Michigan, Ann Arbor, MI, United States.ORCID 0000-0001-9951-7269
Steven ShakExact Sciences, Redwood City, CA, United States.
Priyanka SharmaUniversity of Kansas, Westwood, KS, United States.ORCID 0000-0001-8592-2239
Danika L LewSWOG Statistics and Data Management Center, Seattle, WA, United States.
Jieling MiaoSWOG Statistics and Data Management Center, Seattle, WA, United States.ORCID 0009-0008-9540-453X
Joseph M UngerSWOG Statistics and Data Management Center, Seattle, WA, United States.ORCID 0000-0002-5191-0317
Debasish TripathyThe University of Texas MD Anderson Cancer Center, Houston, TX, United States.
Gabriel N HortobagyiThe University of Texas MD Anderson Cancer Center, Houston, TX, United States.ORCID 0000-0002-4873-4412
Lajos PusztaiYale University, New Haven, CT, United States.ORCID 0000-0001-9632-6686
Kevin KalinskyWinship Cancer Institute at Emory University, Atlanta, GA, United States.

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI DAWN HERSHMAN, PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Michael L. LeBlanc · 2014 to 2026
$115.2M
SWOG NCORP Research BaseUG1CA189974 · NCI · THE HOPE FOUNDATION · PI CHARLES D. BLANKE, DAWN HERSHMAN · 2014 to 2026
$80.6M
NCIC Clinical Trials Group - Canadian Collaborating Clinical Trials NetworkU10CA180863 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI Janet Ellen Dancey · 2014 to 2026
$40.4M
UM LAPs -UG1 GrantUG1CA233160 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ANNE F SCHOTT · 2019 to 2026
$5.4M
AbbVieAstraZenecaBreast Cancer Research FoundationGenomic HealthHope Foundation for Cancer ResearchNCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180863NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189974NCI NIH HHS UG1 CA233160NIH HHS U10CA180888Susan G. Komen for the Cure Research Program
6 · The paper itself

Abstract

backgroundThe phase III RxPONDER trial has affected treatment for node-positive (1-3), hormone receptor-positive, HER2-negative breast cancer with a 21-gene recurrence score (RS) less than 26. We investigated how these findings apply to different racial and ethnic groups within the trial.

methodsThe trial randomly assigned women to endocrine therapy (ET) or to chemotherapy plus ET. The primary clinical outcome was invasive disease-free survival (IDFS), with distant relapse-free survival (DRFS) as a secondary outcome. Multivariable Cox models were used to evaluate the association between race/ethnicity and survival outcomes, adjusting for clinicopathological characteristics, RS, and treatment.

resultsA total of 4048 women with self-reported race/ethnicity were included: Hispanic (15.1%), non-Hispanic Black (NHB) (6.1%), Native American/Pacific Islander (0.8%), Asian (8.0%), and non-Hispanic White (NHW) (70%). No differences in RS distribution, tumor size, or number of positive nodes were observed by race/ethnicity. Relative to NHWs, IDFS was worse for NHB participants (5-year IDFS 91.6% vs 87.1%, HR = 1.37; 95% CI = 1.03 to 1.81) and better for Asians (91.6% vs 93.9%, HR = 0.64; 95% CI = 0.46 to 0.91). Relative to NHW, DRFS was worse for NHB participants (5-year DRFS 95.8% vs 91.0%, HR = 1.65; 95% CI = 1.17 to 2.32) and better for Asians (95.8% vs 96.7%, HR = 0.59; 95% CI = 0.37 to 0.95). Adjusting for clinical characteristics, particularly body mass index, diminished the effect of race on outcomes. Chemotherapy treatment efficacy did not differ by race/ethnicity.

conclusionsNHB women had worse clinical outcomes compared with NHWs in the RxPONDER trial despite similar RS and comparable treatment. Our study emphasizes the persistent racial disparities in breast cancer outcomes while highlighting complex interactions among contributing factors.

trial registrationClinicalTrials.gov: NCT01272037.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesRacial GroupsAdultAgedAntineoplastic Agents, HormonalBlack or African AmericanDisease-Free SurvivalFemaleHispanic or LatinoHumansLymphatic MetastasisMiddle AgedNeoplasm Recurrence, LocalReceptors, EstrogenAntineoplastic Agents, HormonalERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesReceptors, EstrogenReceptors, Progesterone

Identifiers

PMID39656951
PMCPMC12058262

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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.