Evidence map›Paper›PMID 42214557›Full record

ArticleAnnals of oncology : official journal of the European Society for Medical Oncology2026

Updated results of the POSITIVE (Pregnancy Outcome and Safety of Interrupting Therapy for Women with Endocrine Responsive Breast Cancer) trial.

O Pagani, S M Niman, M Ruggeri, F A Peccatori, H A Azim, M Colleoni, C Saura, C Shimizu, A B Sætersdal, J R Kroep and 30 more

Abstract read
In one paragraph

Article in Annals of oncology : official journal of the European Society for Medical Oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

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

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

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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

40 authors.

O PaganiGeneva University Hospitals, Geneva, Switzerland; University Hospitals, Lugano University, Lugano, Switzerland; Swiss Cancer Institute (Formerly SAKK), Bern, Switzerland.
S M NimanInternational Breast Cancer Study Group Statistical Center, Boston, USA; Department of Data Science, Division of Biostatistics, Dana-Farber Cancer Institute, Boston, USA.
M RuggeriProgram for Young Patients, International Breast Cancer Study Group, A Division of ETOP IBCSG Partners Foundation, Bern, Switzerland.
F A PeccatoriFertility and Procreation Unit, Gynecologic Oncology Program, IEO, European Institute of Oncology IRCCS, Milan, Italy.
H A AzimCairo Cure Oncology Center, Cairo, Egypt.
M ColleoniDivision of Medical Senology, IEO, European Institute of Oncology, IRCCS, Milan, Italy.
C SauraVall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; SOLTI Breast Cancer Research Group, Barcelona, Spain.
C ShimizuDepartment of Breast and Medical Oncology, Japan Institute of Health Security - National Center for Global Health and Medicine, Tokyo, Japan.
A B SætersdalBreast Cancer Unit, Department of Oncology, Division of Cancer Medicine, Oslo University Hospital, Oslo, Norway.
J R KroepDepartment of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands; Dutch Breast Cancer Group, BOOG, Utrecht, The Netherlands.
E WarnerOdette Cancer Center, Sunnybrook Health Sciences Center, Toronto, Canada.
F AmantDepartment of Oncology, KU Leuven and Leuven Cancer Institute, Leuven, Belgium; Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium; Antoni van Leeuwenhoek-Netherlands Cancer Institute, Amsterdam, The Netherlands.
A MailliezDepartment of Medical Oncology, Centre Oscar Lambret, Lille, France.
H C F MooreBreast Oncology Program, Cleveland Clinic Taussig Cancer Institute, Cleveland, USA.
M Ruiz-BorregoGEICAM Spanish Breast Cancer Group, Madrid, Spain; Hospital Virgen del Rocio Sevilla, Sevilla, Spain.
J M WalsheCancer Trials Ireland, Dublin, Ireland; Department of Medical Oncology, St. Vincent's University Hospital, Dublin, Ireland.
V F BorgesDivision of Medical Oncology, Department of Medicine, University of Colorado Cancer Center, Aurora, USA.
A GombosInstitut Jules Bordet and Université Libre de Bruxelles, Brussels, Belgium.
A KataokaBreast Oncology Center, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
C Rousset-JablonskiDepartment of Surgery, Leon Berard Cancer Centre, Centre Léon Bérard, Lyon, France; INSERM U1290 RESHAPE, Lyon, France; Gynecology and Obstetrics Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, Bron, France.
S BorstnarDivision of Medical Oncology, Institute of Oncology, Ljubljana, Slovenia; Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
J TakeiSt Luke's International Hospital, Breast Center, Tokyo, Japan.
J E LeeBreast Division, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; Department of Clinical Research and Evaluation, SAIHST, Sungkyunkwan University, Seoul, South Korea.
C SaundersDepartment of Surgery, University of Melbourne, Melbourne, VIC, Australia; Royal Melbourne Hospital, Melbourne, VIC, Australia.
V Bjelic-RadisicBreast Unit, Helios University Clinic Wuppertal, University Witten/Herdecke, Wuppertal, Germany; Austrian Breast and Colorectal Study Group (ABCSG), Vienna, Austria.
S SusnjarDepartment of Medical Oncology, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.
F CardosoBreast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Advanced Breast Cancer (ABC) Global Alliance Lisbon, Lisbon, Portugal.
N J KlarNew York University Langone's Perlmutter Cancer Center, Breast Cancer Center, New York, USA.
T FerreiroSoul Reconnect, Barcelona, Spain.
K RibiQuality of Life Office, International Breast Cancer Study Group, A Division of ETOP IBCSG Partners Foundation, Bern, Switzerland; Careum School of Health, Part of the Kalaidos University of Applied Sciences, Zurich, Switzerland.
K J RuddyDepartment of Oncology, Mayo Clinic, Rochester, USA.
R KammlerTranslational Research Coordination, International Breast Cancer Study Group, A Division of ETOP IBCSG Partners Foundation, Bern, Switzerland.
S El-AbedBreast International Group (BIG), Brussels, Belgium.
G VialeInternational Breast Cancer Study Group Central Pathology Office, Bern, Switzerland; Department of Pathology and Laboratory Medicine, IEO, European Institute of Oncology, IRCCS, Milan, Italy.
M PiccartInstitut Jules Bordet and Université Libre de Bruxelles, Brussels, Belgium; Breast International Group (BIG), Brussels, Belgium.
L A KordeJazz Pharmaceuticals, Philadelphia, USA.
A GoldhirschInternational Breast Cancer Study Group, A Division of ETOP IBCSG Partners Foundation, Bern, Switzerland; IEO, European Institute of Oncology, IRCCS, Milan, Italy.
R D GelberInternational Breast Cancer Study Group Statistical Center, Boston, USA; Department of Data Science, Division of Biostatistics, Dana-Farber Cancer Institute, Boston, USA; Frontier Science and Technology Research Foundation, Boston, USA; Harvard TH Chan School of Public Health, Boston, USA; Harvard Medical School, Boston, USA.
A H PartridgeHarvard Medical School, Boston, USA; Medical Oncology, Dana-Farber Cancer Institute, Boston, USA. Electronic address: ann_partridge@dfci.harvard.edu.
International Breast Cancer Study Group and the POSITIVE Trial Consortium

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
ECOG-ACRIN NCORP Research Base - TMISTUG1CA189828 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$199.7M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
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
THE ALLIANCE NCTN BIOREPOSITORY AND BIOSPECIMEN RESOURCEU24CA196171 · NCI · WASHINGTON UNIVERSITY · PI Mine Cicek, Wendy Frankel · 2015 to 2026
$35.0M
NCI NIH HHS U10 CA180863NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS U24 CA196171NCI NIH HHS UG1 CA189823NCI NIH HHS UG1 CA189828NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA189974
6 · The paper itself

Abstract

backgroundIn patients with hormone receptor (HR)-positive early breast cancer (BC), the POSITIVE trial demonstrated that temporary interruption of adjuvant endocrine therapy (ET) for pregnancy is feasible and safe in early follow-up (median 41 months). In this article, we report updated results from a preplanned analysis with 2.5 years of additional follow-up. PATIENTS AND

methodsPOSITIVE, a single-arm prospective trial evaluating temporary interruption of adjuvant ET (after 18-30 months and for up to 2 years) to attempt pregnancy in young patients with BC, enrolled 518 eligible women (≤42 years of age, stage I-III BC, desiring pregnancy) from December 2014 to December 2019. Using the bootstrap-matching method, 5-year breast cancer-free interval (BCFI) and distant recurrence-free interval (DRFI) event rates were compared with those of the SOFT/TEXT trials as external controls.

resultsAt a median follow-up of 71 months in the POSITIVE cohort and 80 months in the SOFT/TEXT cohort, the 5-year cumulative incidence of BCFI events was 12.3% in POSITIVE and 13.2% in SOFT/TEXT [-0.9% difference, 95% confidence interval (CI) -4.2% to 2.6%]. The 5-year cumulative incidence of DRFI events was 6.2% and 8.3%, respectively (-2.1% difference, 95% CI -4.5% to 0.4%). Among 497 women followed for nondisease outcomes, 377 (76%) had ≥1 documented pregnancy on trial, and 343 of 497 (69%) had ≥1 live birth, totaling 440 offspring. In an unadjusted analysis comparing the 180 women (36%) who had pre-enrollment embryo/oocyte cryopreservation with those who did not, the 5-year cumulative incidence of BCFI events was 14.0% (95% CI 9.6% to 20.2%) and 11.5% (95% CI 8.4% to 15.7%), respectively.

conclusionLonger-term follow-up of the POSITIVE trial demonstrates that temporary interruption of ET for pregnancy, including use of fertility preservation, does not increase the risk of BC events. Continued follow-up is warranted given the known risk of late recurrence in this population.

Indexed as

Antineoplastic Agents, HormonalBreast NeoplasmsNeoplasm Recurrence, LocalPregnancy Complications, NeoplasticAdultChemotherapy, AdjuvantFemaleFollow-Up StudiesHumansPregnancyPregnancy OutcomeProspective StudiesTreatment InterruptionAntineoplastic Agents, Hormonalbreast cancerendocrine therapy interruptionpregnancyyoung women

Identifiers

PMID42214557
PMCPMC13501236

What OpenQuestion holds

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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.