AzTrials
AzTrials

Early Breast CancerPOSITIVENCT02308085

Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer

A study testing Endocrine therapy interruption in people with Early Breast Cancer, run by ETOP IBCSG Partners Foundation at 211 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. Read more about this study

Who is it for?
Ages 18 to 42 years, women only
Conditions the study is for
Early Breast Cancer
What is being tested?
Endocrine therapy interruption
Could I receive a placebo?
No, everyone receives an active treatment
How many people
518 participants
Where
211 sitesin 22 countries
Study dates
4 Dec 2014to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 42 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age ≥ 18 and ≤ 42 years at enrollment.
  • Has received adjuvant endocrine therapy (SERM alone, GnRH analogue plus SERM or AI) for ≥18 months but ≤30 months for early breast cancer.
  • Note: Patients who have received neo/adjuvant endocrine treatment within a clinical trial and patients who have received pharmaco-prevention are eligible.
  • The adjuvant endocrine therapy must have stopped within 1 month prior to enrollment.
  • Patient wishes to become pregnant. Note: Patients who have undergone oocyte/embryo/ovarian tissue cryopreservation at breast cancer diagnosis and/or have a previous history of assisted reproductive technology (ART) are eligible.
  • Breast cancer for which patient is receiving endocrine therapy must have been histologically-proven stage I-III, endocrine-responsive (i.e., estrogen and/or progesterone receptor positive, according to local definition of positive, determined using immunohistochemistry (IHC)), and treated with curative intent.
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  • Note:
  • Patients with synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) are eligible.
  • Patient with invasive breast cancer or synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) during pregnancy are eligible.
  • Patients with BRCA1/2 mutations are eligible.
  • Patients could have received neo/adjuvant chemotherapy, or other systemic therapy (e.g., neo/adjuvant HER2-targeted therapy) according to institutional policy and patient's desire.
  • Patient must be premenopausal at breast cancer diagnosis, as determined locally and documented in patient record.
  • Patient must be without clinical evidence of loco-regional and distant disease, as evaluated according to institutional assessment standards and documented in the patient record.
  • Written informed consent (IC) for trial participation must be signed and dated by the patient and the investigator prior to enrollment.
  • Written consent to biological material submission, indicating the patient has been informed of and agrees to tissue and blood material use, transfer and handling, must be signed and dated by the patient and the investigator prior to any procedures specific for this trial.
  • The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
  • Patient must be accessible for follow-up.

Who cannot join

  • Post-menopausal patients at BC diagnosis, as determined locally.
  • History of hysterectomy, bilateral oophorectomy or ovarian irradiation.
  • Patients with current local, loco-regional relapse and/or distant metastatic breast cancer.
  • Patients with a history of prior (ipsi- and/or contralateral) invasive BC.
  • Patients with previous or concomitant non-breast invasive malignancy.
  • Exceptions are limited exclusively to patients with the following previous malignancies, if adequately treated: basal or squamous cell carcinoma of the skin, in situ non-breast carcinoma, contra- or ipsilateral in situ breast carcinoma, stage Ia carcinoma of the cervix.
Show all 9Show fewer
  • Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient's safety.
  • Patients with a history of noncompliance to medical treatments and/or considered potentially unreliable.
  • Patients with psychiatric, addictive, or any disorder that would prevent compliance with protocol requirements.

Trial locations and contacts

211 sites in 22 countries.

211 sites in 22 countries

United States103 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48103

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado Cancer Centre - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Greater Baltimore Medical Centre

    Baltimore, Maryland, 21204

  • Johns Hopkins University

    Baltimore, Maryland, 21218

  • Sanford Clinic North - Bemidji

    Bemidji, Minnesota, 56501

  • Sanford Bismark Medical Centre

    Bismarck, North Dakota, 58501

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215-5450

  • Rocky Mountain Cancer Center

    Boulder, Colorado, 80303

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • IHA Hematology Consultants-Brighton

    Brighton, Michigan, 48114

  • Saint Joseph Mercy Hospital - Brighton

    Brighton, Michigan, 48114

  • University of Vermont Medical Centre

    Burlington, Vermont, 05401

  • IHA Hematology Consultants-Canton

    Canton, Michigan, 48188

  • Saint Joseph Mercy Hospital- Canton

    Canton, Michigan, 48188

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • IHA Hematology Consultants-Chelsea

    Chelsea, Michigan, 48118

  • Saint Joseph Mercy Hospital - Chelsea

    Chelsea, Michigan, 48118

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Southeastern Medical Oncology Centre

    Clinton, North Carolina, 28328

  • Ohio State University

    Columbus, Ohio, 43210

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Carle on Vermilion

    Danville, Illinois, 61832

  • SCL Health Saint Joseph Hospital

    Denver, Colorado, 80218

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805-1951

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Carle Physician Group - Effingham

    Effingham, Illinois, 62401

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Northwestern University

    Evanston, Illinois, 60201

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824

  • Sanford Roger Maris Cancer Centre

    Fargo, North Dakota, 58102

  • Sanford Medical Centre

    Fargo, North Dakota, 58122

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • NorthShore University Health System - Glenbrook Hospital

    Glenview, Illinois, 60026

  • Southeastern Medical Oncology Centre

    Goldsboro, North Carolina, 27534

  • Greenville Health System Cancer Institute-Butternut

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29611

  • Greenville Health System Cancer Institute-Greer

    Greer, South Carolina, 29650

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina

  • NorthShore Unversity Health System - Highland Park Hospital

    Highland Park, Illinois, 60035

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96701

  • OnCare Hawaii Inc - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Centre

    Honolulu, Hawaii, 96813

  • OnCare Hawaii-Kuakini

    Honolulu, Hawaii, 96817

  • Indiana University

    Indianapolis, Indiana, 46202

  • Southeastern Medical Oncology Centre

    Jacksonville, North Carolina, 28546

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78045

  • Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • Cedars Sinai Medical Centre

    Los Angeles, California, 90211

  • St John's Hospital

    Maplewood, Minnesota, 55109

  • Mattoon Charleston Primary Care

    Mattoon, Illinois, 61938

  • Bon Secours Memorial Regional Medical Centre

    Mechanicsville, Virginia, 23116

  • Bon Secours Saint Francis Medical Centre

    Midlothian, Virginia, 23114

  • Abbott-Northwestern Hospital, 800 East 28th Street

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Cancer Center

    Minneapolis, Minnesota, 55415

  • Yale University - Yale Cancer Centre

    New Haven, Connecticut, 06520

  • Weill Medical College of Cornell University

    New York, New York, 10065

  • Helen F. Graham Cancer Center

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Medical Oncology Hematology Consultants PA

    Newport, Delaware, 19713

  • Regional Hematology Oncology Practice Associates

    Newport, Delaware, 19713

  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473

  • Smilow Cancer Hospital-Orange Care Center

    Orange, Connecticut, 06477

  • Chagrin Highlands

    Orange, Ohio, 44122

  • Stanford Cancer Institute

    Palo Alto, California, 94305

  • UPMC-Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • Bon Secours Saint Mary's Hospital

    Richmond, Virginia, 23223

  • Mayo Clinic

    Rochester, Minnesota, 55902

  • Park Nicollet Methodist Hospital

    Saint Louis Park, Minnesota, 55343

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Huntsman Cancer Institute / University of Utah

    Salt Lake City, Utah, 84112

  • Sharp Memorial Hospital

    San Diego, California

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Greenville Health System Cancer Institute-Seneca

    Seneca, South Carolina, 29672

  • Sanford Cancer Centre Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Centre - Sioux Falls

    Sioux Falls, South Dakota, 57104

  • NorthShore Medical Centre

    Skokie, Illinois, 60076

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Greenville Health System Cancer Institute-Spartanburg

    Spartanburg, South Carolina, 29307

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Montefiore Medical Center - Einstein Campus, 1695 Eastchester Road

    The Bronx, New York, 10461

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus, 111 East 210th Street

    The Bronx, New York, 10467

  • Smilow Cancer Hospital-Torrington Care Center

    Torrington, Connecticut, 06790

  • Smilow Cancer Hospital Care Center-Trumbull

    Trumbull, Connecticut, 06611

  • Carle Cancer Centre

    Urbana, Illinois, 61801

  • The Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • Smilow Cancer Hospital-Waterbury Care Center

    Waterbury, Connecticut, 06708

  • Dickstein Cancer Treatment Centre

    White Plains, New York, 10601

  • Southeastern Medical Oncology Centre

    Wilson, North Carolina, 27534

  • IHA Hematology Oncology Consultants-Ann Arbor

    Ypsilanti, Michigan, 48198

Other trials in United States

Japan18 sites

  • Kansai Rosai Hospital

    Amagasaki, Hyōgo, 660-8511

  • NHO Kyushu Cancer Centre, 3-1-1 Notame Minami-ku Fukuoka-shi

    Fukuoka, 811-1395

  • Seirei Hamamatsu General Hospital

    Hamamatsu, Shizuoka

  • Social Medical Corporation Hakuaikai Sagara Hospital

    Kagoshima

  • St Marianna University School of Medicine Hospital

    Kawasaki

  • Kyoto University Hospital

    Kyoto

  • NHO Shikoku Cancer Center

    Matsuyama

  • Toranomon Hospital

    Minato-ku, Tokyo, 105-8470

  • Kamiiida Daiichi General Hospital

    Nagoya, 463-0802

  • Okayama University Hospital

    Okayama

  • NHO Osaka National Hospital

    Ōsaka

  • Tohoku University Hospital

    Sendai

  • National Cancer Center for Global Medicine

    Tokyo

  • National Cancer Center Hospital

    Tokyo

  • Showa University Hospital

    Tokyo

  • St Luke's International Hospital

    Tokyo

  • The Cancer Institute Hospital of JFCR

    Tokyo

  • University of Tsukuba

    Tsukuba

Other trials in Japan

Spain18 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital General de Catalunya

    Barcelona

  • Hospital Universitario Donostia

    Donostia / San Sebastian

  • Hospital Clinico Universitario Virgen de la Arrixaca

    El Palmar, Murcia

  • Instituto Catalán de Oncología de Gerona Hospital

    Girona

  • Hospital Universitario HM Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)

    Madrid, 28050

  • Hospital Clinico San Carlos

    Madrid

  • Hospital Universitario de Fuenlabrada

    Madrid

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Central de Asturias

    Oviedo

  • Hospital Son Espases, Palma de Mallorca

    Palma

  • Complejo Hospitalario de Navarra

    Pamplona

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela

  • Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Quiron Sagrado Corazon

    Seville

  • Hospital Virgen De La Salud

    Toledo

  • Hospital General Universitario de Valencia - Servico Oncologia

    Valencia

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza

Other trials in Spain

Italy16 sites

  • Centro di Riferimento Oncologico

    Aviano, 33081

  • Ospedale degli Infermi - S. C. Oncologia Medica

    Biella

  • Azienda Sanitaria di Bolzano

    Bolzano, 39100

  • U.O Medicina Oncologica Ospedale di Carpi

    Carpi, Modena, 41012

  • Multimedica Spa

    Castellanza, Vareze

  • Istituto Nazionale Ricerca Cancro

    Genova

  • Istituto scientifico Romagnolo per lo studio e la cura

    Meldola

  • Istituto Europeo di Oncologia (IEO)

    Milan, 20141

  • University of Eastern Piedmont

    Novara, 28100

  • Salvatore Maugeri Foundation - Medical Oncology Unit

    Pavia, 27100

  • Ospedale di Prato

    Prato, Firenze

  • UO Oncologia, Rimini Hospital

    Rimini, 47923

  • Regina Elena National Cancer Institute

    Rome

  • Ospedale di Trento

    Trento, Trento, 38122

  • AO Universitaria Ospedale Di Circolo e Fondazione

    Varese, 21100

  • Ospedale Belcolle di Viterbo

    Viterbo

Other trials in Italy

Switzerland13 sites

  • Kantonspital Baden AG

    Baden, 5404

  • Universitätsspital Basel

    Basel, 4031

  • Istituto Oncologico della Svizzera Italiana (IOSI)

    Bellinzona

  • Inselspital Bern

    Bern, Canton of Bern, 3010

  • Oncocare Bern

    Bern, 3012

  • Brustzentrum Thurgau - Obstetrics and Gynecology

    Frauenfeld

  • University Hospital Geneva

    Geneva, 1211

  • University Hospital of Lausanne (CHUV) BH06 - Oncology Department

    Lausanne

  • Brustzentum Kantonsspital St. Gallen

    Sankt Gallen, 9007

  • CHCVs Hôpital de Sion - Service d'oncologie ambulatoire

    Sion, 736

  • Spital STS AG Onkologiezentrum Thun-Berner Oberland

    Thun, Canton of Bern, 3600

  • Brust-Zentrum AG

    Zurich, 8008

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

Canada8 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • CHA-Hopital Du St-Sacrement

    Québec, Quebec, G1S 4L8

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec

  • St Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • Odette Cancer Centre - Sunnybrook Health Sciences Centre

    Toronto, Ontario

  • Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Belgium6 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Cliniques Universitaires Saint-Luc Brussels

    Brussels

  • Institut Jules Bordet

    Brussels

  • UZ Leuven

    Leuven, 3000

  • C.H.U. Sart-Tilman

    Liège, 4000

  • Clinique St.Elizabeth

    Namur, 5000

Other trials in Belgium

Ireland5 sites

  • St Vincent's University Hospital

    Dublin

  • St. James's Hospital

    Dublin

  • Galway University Hospital

    Galway

  • University Hospital Limerick

    Limerick

  • University Hospital Waterford

    Waterford

Other trials in Ireland

Austria4 sites

  • Univ. Klinik f. Frauenheilkunde u. Geburtshilfe

    Graz, 8036

  • Univ. Klinik f. Frauenheilkunde Innsbruck

    Innsbruck, 6020

  • LKH Salzburg

    Salzburg, 5020

  • Med. Univ. Klinik f. Chir

    Vienna, 1090

Other trials in Austria

France4 sites

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Oscar Lambret

    Lille, 59020

  • French Lyon Cancer Center

    Lyon, 69373

  • APHP, Tenon Hospital in Paris

    Paris

Other trials in France

South Korea3 sites

  • Samsung Medical Center

    Seoul, 06351

  • Asan Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

Greece2 sites

  • Laso General Hospital, First Department of Medical Oncology

    Athens

  • University General Hospital of Heraklion

    Stavrakia, Crete, 71110

Other trials in Greece

Israel2 sites

  • Shaare Zedek Medical Center

    Jerusalem

  • Chaim Sheba Medical Center

    Tel HaShomer, 5265601

Other trials in Israel

Australia1 site

  • St John of God Subiaco Hospital

    Perth, Western Australia, 6008

Other trials in Australia

Denmark1 site

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

Hungary1 site

  • Debrecen University Dep. of Oncology

    Debrecen

Other trials in Hungary

Lebanon1 site

  • American University of Beirut Medical Center

    Beirut

Other trials in Lebanon

Netherlands1 site

  • Leiden University Medical Centre, Albinusdreef 2, Postbus 9600

    Leiden, 2300 RC

Other trials in Netherlands

Norway1 site

  • Norwegian Radium Hospital (Oslo University)

    Oslo

Other trials in Norway

Portugal1 site

  • Champalimaud Cancer Center - Breast Cancer Unit

    Lisbon

Other trials in Portugal

Serbia1 site

  • Institute of Oncology & Radiology of Serbia

    Belgrade

Other trials in Serbia

Slovenia1 site

  • Institute of Oncology Ljubljana - Medical Oncology Department

    Ljubljana

Other trials in Slovenia

About this study

Official title: A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women With Endocrine Responsive Breast Cancer Who Desire Pregnancy

The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers.

Read the detailed description

Recent decades have witnessed a delay in childbearing for a variety of reasons including cultural, educational, and professional. As a consequence, breast cancer in young women often occurs before the completion of reproductive plans. Infertility has a significant impact on quality of life, resulting in substantial distress in younger women with breast cancer and influencing treatment decisions in a consistent proportion of patients.The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence.For women desiring pregnancy after a breast cancer, 5-10 years of endocrine therapy may substantially reduce the chance of conception; however, a shorter duration of endocrine therapy in this population has not been studied in a prospective manner.

Birth outcome after breast cancer has not been shown to be different from that of the normal population, but increased risks of delivery complications, cesarean section, preterm birth and low birth weight have been reported.

Endocrine agents are potentially teratogenic: taking into account their median half-life, waiting 3 months after their interruption before attempting conception is considered safe.

The limited evidence available on breastfeeding after breast cancer reports successful lactation from the treated breast in approximately 30% of women without detrimental effect on survival. No prospective definitive data are available.

Being tested
Endocrine therapy interruption
Keywords
Premenopausal, endocrine responsive, Breast, Pregnancy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endocrine therapy interruptionOther

    3 months wash-out between treatment interruption and pregnancy attempt. Up to 2 years interruption to allow pregnancy, delivery, breastfeeding or failure to conceive.

    Endocrine therapy resumption. Completion of full duration of endocrine therapy according to individual risk, institutional policy or patient's preference.

Study groups in NCT02308085
Study groupRoleWhat they receive
Endocrine therapy interruptionExperimentalEndocrine therapy interruption after having completed between ≥ 18 months and ≤ 30 months.
Receives: Other: Endocrine therapy interruption

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breast Cancer free interval (BCFI)

    Kaplan-Meier Analysis

    Measured: From enrollment until the first invasive BC event, assessed up to 14 years

Secondary outcomes (7)

  1. Information on Menstruation recovery and pattern

    Menstrual diary

    Measured: Up to 24 months after enrollment

  2. Pregnancy rate (determined by pregnancy test)

    Pregnancy test

    Measured: Up to 24 months after enrollment

  3. Pregnancy outcome

    Labor and delivery Information, full term pregnancy, caesarean section, abortion, miscarriage, ectopic, stillbirth rates.

    Measured: Up to 33 months after enrollment

  4. Offspring outcome

    Collect information on preterm birth, low birth weight, births defects rates.

    Measured: Up to 33 months after enrollment

  5. Breastfeeding pattern

    Analysis of pattern e.g Duration, use of ipsilateral breast if previous breast conservation, side exclusivity

    Measured: Up to 36 months after enrollment

  6. Use of assisted reproductive Technology (ART)

    ART use will be tabulated

    Measured: Up to 24 months after enrollment

  7. Distant recurrence-free interval (DRFI)

    Kaplan-Meier Analysis

    Measured: Time from enrollment in the study to the first breast cancer recurrence in a distant site, assessed up to 14 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2014 (estimated)
  2. Study start4 Dec 2014
  3. Primary completion15 May 2025
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
518 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02308085
Sponsor's protocol ID
IBCSG 48-14 / BIG 8-13
Other IDs
Alliance A221405, NCIC CTG MAC.18
Acronym
POSITIVE
Status last verified
Feb 2026
First submitted
21 Nov 2014
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Brinton LA, Sherman ME, Carreon JD, Anderson WF. Recent trends in breast cancer among younger women in the United States. J Natl Cancer Inst. 2008 Nov 19;100(22):1643-8. doi: 10.1093/jnci/djn344. Epub 2008 Nov 11.

    PubMed 19001605

  • Leclere B, Molinie F, Tretarre B, Stracci F, Daubisse-Marliac L, Colonna M; GRELL Working Group. Trends in incidence of breast cancer among women under 40 in seven European countries: a GRELL cooperative study. Cancer Epidemiol. 2013 Oct;37(5):544-9. doi: 10.1016/j.canep.2013.05.001. Epub 2013 Jun 12.

    PubMed 23768969

  • Bentzon N, During M, Rasmussen BB, Mouridsen H, Kroman N. Prognostic effect of estrogen receptor status across age in primary breast cancer. Int J Cancer. 2008 Mar 1;122(5):1089-94. doi: 10.1002/ijc.22892.

    PubMed 17960621

  • Anders CK, Hsu DS, Broadwater G, Acharya CR, Foekens JA, Zhang Y, Wang Y, Marcom PK, Marks JR, Febbo PG, Nevins JR, Potti A, Blackwell KL. Young age at diagnosis correlates with worse prognosis and defines a subset of breast cancers with shared patterns of gene expression. J Clin Oncol. 2008 Jul 10;26(20):3324-30. doi: 10.1200/JCO.2007.14.2471.

    PubMed 18612148

  • Demeestere I, Niman SM, Partridge AH, Diego DS, Kammler R, Ruggeri M, Colleoni M, Shimizu C, Saura C, Gelmon KA, Saetersdal AB, Kroep JR, Mailliez A, Amant F, Ruiz-Borrego M, Lee JE, Kataoka A, Walshe JM, Takei J, Borstnar S, Borges VF, Saunders C, Susnjar S, Bjelic-Radisic V, Cardoso F, Meisel JL, Kawwass JF, Spanic T, El-Abed S, Piccart M, Korde LA, Goldhirsch A, Gelber RD, Pagani O, Azim HA Jr, Peccatori FA; International Breast Cancer Study Group and the POSITIVE Trial Collaborators. Hormonal factors predictive of fertility in patients with breast cancer interrupting adjuvant endocrine therapy to attempt pregnancy in POSITIVE trial. Breast. 2025 Oct;83:104547. doi: 10.1016/j.breast.2025.104547. Epub 2025 Jul 26.

    PubMed 40743662

  • Peccatori FA, Niman SM, Partridge AH, Ruggeri M, Colleoni M, Saura C, Shimizu C, Satersdal AB, Kroep JR, Gelmon K, Amant F, Mailliez A, Moore HCF, Ruiz-Borrego M, Walshe JM, Borges VF, Gombos A, Kataoka A, Rousset-Jablonski C, Borstnar S, Takei J, Lee JE, Saunders C, Bjelic-Radisic V, Susnjar S, Cardoso F, Klar NJ, Ferreiro T, El-Abed S, Piccart M, Korde LA, Goldhirsch A, Gelber RD, Pagani O, Azim HA Jr; International Breast Cancer Study Group and the POSITIVE Trial Collaborators. Breastfeeding After Hormone Receptor-Positive Breast Cancer: Results From the POSITIVE Trial. J Clin Oncol. 2025 Aug 20;43(24):2712-2719. doi: 10.1200/JCO-24-02697. Epub 2025 Jul 9.

    PubMed 40632989

  • Partridge AH, Niman SM, Ruggeri M, Peccatori FA, Azim HA Jr, Colleoni M, Saura C, Shimizu C, Saetersdal AB, Kroep JR, Mailliez A, Warner E, Borges VF, Amant F, Gombos A, Kataoka A, Rousset-Jablonski C, Borstnar S, Takei J, Lee JE, Walshe JM, Ruiz-Borrego M, Moore HCF, Saunders C, Bjelic-Radisic V, Susnjar S, Cardoso F, Smith KL, Ferreiro T, Ribi K, Ruddy K, Kammler R, El-Abed S, Viale G, Piccart M, Korde LA, Goldhirsch A, Gelber RD, Pagani O; International Breast Cancer Study Group; POSITIVE Trial Collaborators. Interrupting Endocrine Therapy to Attempt Pregnancy after Breast Cancer. N Engl J Med. 2023 May 4;388(18):1645-1656. doi: 10.1056/NEJMoa2212856.

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  • Perachino M, Poggio F, Arecco L, Blondeaux E, Spinaci S, Marrocco C, Levaggi A, Lambertini M. Update on Pregnancy Following Breast Cancer Diagnosis and Treatment. Cancer J. 2022 May-Jun 01;28(3):176-182. doi: 10.1097/PPO.0000000000000599.

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Questions about this trial

What is this clinical trial studying?

A study testing Endocrine therapy interruption in people with Early Breast Cancer, run by ETOP IBCSG Partners Foundation at 211 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 211 sites in United States, Japan, Spain, Italy, Switzerland and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breast Cancer free interval (BCFI) (time frame: From enrollment until the first invasive BC event, assessed up to 14 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02308085, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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