NCT02308085

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
518

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
21 countries

210 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Dec 2014Dec 2028

First Submitted

Initial submission to the registry

November 21, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

December 4, 2014

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Expected
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

10.5 years

First QC Date

November 21, 2014

Last Update Submit

February 5, 2026

Conditions

Keywords

Premenopausalendocrine responsiveBreastPregnancy

Outcome Measures

Primary Outcomes (1)

  • Breast Cancer free interval (BCFI)

    Kaplan-Meier Analysis

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

Secondary Outcomes (7)

  • Information on Menstruation recovery and pattern

    Up to 24 months after enrollment

  • Pregnancy rate (determined by pregnancy test)

    Up to 24 months after enrollment

  • Pregnancy outcome

    Up to 33 months after enrollment

  • Offspring outcome

    Up to 33 months after enrollment

  • Breastfeeding pattern

    Up to 36 months after enrollment

  • +2 more secondary outcomes

Study Arms (1)

Endocrine therapy interruption

EXPERIMENTAL

Endocrine therapy interruption after having completed between ≥ 18 months and ≤ 30 months.

Other: Endocrine therapy interruption

Interventions

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.

Endocrine therapy interruption

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • 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.
  • +2 more criteria

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (211)

Cedars Sinai Medical Centre

Los Angeles, California, 90211, United States

Location

Stanford Cancer Institute

Palo Alto, California, 94305, United States

Location

Sharp Memorial Hospital

San Diego, California, United States

Location

University of Colorado Cancer Centre - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Rocky Mountain Cancer Center

Boulder, Colorado, 80303, United States

Location

SCL Health Saint Joseph Hospital

Denver, Colorado, 80218, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, 06418, United States

Location

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, 06824, United States

Location

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States

Location

Yale University - Yale Cancer Centre

New Haven, Connecticut, 06520, United States

Location

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, 06473, United States

Location

Smilow Cancer Hospital-Orange Care Center

Orange, Connecticut, 06477, United States

Location

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, 06790, United States

Location

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611, United States

Location

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, 06708, United States

Location

Helen F. Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

Medical Oncology Hematology Consultants PA

Newport, Delaware, 19713, United States

Location

Regional Hematology Oncology Practice Associates

Newport, Delaware, 19713, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Straub Clinic and Hospital

Honolulu, Hawaii, 96701, United States

Location

OnCare Hawaii Inc - POB I

Honolulu, Hawaii, 96813, United States

Location

Queen's Medical Centre

Honolulu, Hawaii, 96813, United States

Location

OnCare Hawaii-Kuakini

Honolulu, Hawaii, 96817, United States

Location

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Carle on Vermilion

Danville, Illinois, 61832, United States

Location

Carle Physician Group - Effingham

Effingham, Illinois, 62401, United States

Location

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Northwestern University

Evanston, Illinois, 60201, United States

Location

NorthShore University Health System - Glenbrook Hospital

Glenview, Illinois, 60026, United States

Location

NorthShore Unversity Health System - Highland Park Hospital

Highland Park, Illinois, 60035, United States

Location

Mattoon Charleston Primary Care

Mattoon, Illinois, 61938, United States

Location

NorthShore Medical Centre

Skokie, Illinois, 60076, United States

Location

Carle Cancer Centre

Urbana, Illinois, 61801, United States

Location

The Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Greater Baltimore Medical Centre

Baltimore, Maryland, 21204, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215-5450, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48103, United States

Location

IHA Hematology Consultants-Brighton

Brighton, Michigan, 48114, United States

Location

Saint Joseph Mercy Hospital - Brighton

Brighton, Michigan, 48114, United States

Location

IHA Hematology Consultants-Canton

Canton, Michigan, 48188, United States

Location

Saint Joseph Mercy Hospital- Canton

Canton, Michigan, 48188, United States

Location

IHA Hematology Consultants-Chelsea

Chelsea, Michigan, 48118, United States

Location

Saint Joseph Mercy Hospital - Chelsea

Chelsea, Michigan, 48118, United States

Location

IHA Hematology Oncology Consultants-Ann Arbor

Ypsilanti, Michigan, 48198, United States

Location

Sanford Clinic North - Bemidji

Bemidji, Minnesota, 56501, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Essentia Health Cancer Center

Duluth, Minnesota, 55805-1951, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

St John's Hospital

Maplewood, Minnesota, 55109, United States

Location

Abbott-Northwestern Hospital, 800 East 28th Street

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center - Cancer Center

Minneapolis, Minnesota, 55415, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Park Nicollet Methodist Hospital

Saint Louis Park, Minnesota, 55343, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center - Einstein Campus, 1695 Eastchester Road

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center-Weiler Hospital

The Bronx, New York, 10461, United States

Location

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

The Bronx, New York, 10467, United States

Location

Dickstein Cancer Treatment Centre

White Plains, New York, 10601, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Southeastern Medical Oncology Centre

Clinton, North Carolina, 28328, United States

Location

Southeastern Medical Oncology Centre

Goldsboro, North Carolina, 27534, United States

Location

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Location

Southeastern Medical Oncology Centre

Jacksonville, North Carolina, 28546, United States

Location

Southeastern Medical Oncology Centre

Wilson, North Carolina, 27534, United States

Location

Sanford Bismark Medical Centre

Bismarck, North Dakota, 58501, United States

Location

Sanford Roger Maris Cancer Centre

Fargo, North Dakota, 58102, United States

Location

Sanford Medical Centre

Fargo, North Dakota, 58122, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Chagrin Highlands

Orange, Ohio, 44122, United States

Location

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Greenville Health System Cancer Institute-Butternut

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Eastside

Greenville, South Carolina, 29611, United States

Location

Greenville Health System Cancer Institute-Greer

Greer, South Carolina, 29650, United States

Location

Greenville Health System Cancer Institute-Seneca

Seneca, South Carolina, 29672, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

Sanford Cancer Centre Oncology Clinic

Sioux Falls, South Dakota, 57104, United States

Location

Sanford USD Medical Centre - Sioux Falls

Sioux Falls, South Dakota, 57104, United States

Location

Doctor's Hospital of Laredo

Laredo, Texas, 78045, United States

Location

Huntsman Cancer Institute / University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Vermont Medical Centre

Burlington, Vermont, 05401, United States

Location

Bon Secours Memorial Regional Medical Centre

Mechanicsville, Virginia, 23116, United States

Location

Bon Secours Saint Francis Medical Centre

Midlothian, Virginia, 23114, United States

Location

Bon Secours Saint Mary's Hospital

Richmond, Virginia, 23223, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

St John of God Subiaco Hospital

Perth, Western Australia, 6008, Australia

Location

Univ. Klinik f. Frauenheilkunde u. Geburtshilfe

Graz, 8036, Austria

Location

Univ. Klinik f. Frauenheilkunde Innsbruck

Innsbruck, 6020, Austria

Location

LKH Salzburg

Salzburg, 5020, Austria

Location

Med. Univ. Klinik f. Chir

Vienna, 1090, Austria

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Cliniques Universitaires Saint-Luc Brussels

Brussels, Belgium

Location

Institut Jules Bordet

Brussels, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

C.H.U. Sart-Tilman

Liège, 4000, Belgium

Location

Clinique St.Elizabeth

Namur, 5000, Belgium

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Odette Cancer Centre - Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

Location

CHA-Hopital Du St-Sacrement

Québec, Quebec, G1S 4L8, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

French Lyon Cancer Center

Lyon, 69373, France

Location

APHP, Tenon Hospital in Paris

Paris, France

Location

University General Hospital of Heraklion

Stavrakia, Crete, 71110, Greece

Location

Laso General Hospital, First Department of Medical Oncology

Athens, Greece

Location

Debrecen University Dep. of Oncology

Debrecen, Hungary

Location

St Vincent's University Hospital

Dublin, Ireland

Location

St. James's Hospital

Dublin, Ireland

Location

Galway University Hospital

Galway, Ireland

Location

University Hospital Limerick

Limerick, Ireland

Location

University Hospital Waterford

Waterford, Ireland

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Chaim Sheba Medical Center

Tel Litwinsky, 5265601, Israel

Location

Ospedale di Prato

Prato, Firenze, Italy

Location

U.O Medicina Oncologica Ospedale di Carpi

Carpi, Modena, 41012, Italy

Location

Ospedale di Trento

Trento, Trento, 38122, Italy

Location

Multimedica Spa

Castellanza, Vareze, Italy

Location

Centro di Riferimento Oncologico

Aviano, 33081, Italy

Location

Ospedale degli Infermi - S. C. Oncologia Medica

Biella, Italy

Location

Azienda Sanitaria di Bolzano

Bolzano, 39100, Italy

Location

Istituto Nazionale Ricerca Cancro

Genova, Italy

Location

Istituto scientifico Romagnolo per lo studio e la cura

Meldola, Italy

Location

Istituto Europeo di Oncologia (IEO)

Milan, 20141, Italy

Location

University of Eastern Piedmont

Novara, 28100, Italy

Location

Salvatore Maugeri Foundation - Medical Oncology Unit

Pavia, 27100, Italy

Location

UO Oncologia, Rimini Hospital

Rimini, 47923, Italy

Location

Regina Elena National Cancer Institute

Rome, Italy

Location

AO Universitaria Ospedale Di Circolo e Fondazione

Varese, 21100, Italy

Location

Ospedale Belcolle di Viterbo

Viterbo, Italy

Location

Kansai Rosai Hospital

Amagasaki, Hyōgo, 660-8511, Japan

Location

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan

Location

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

Fukuoka, 811-1395, Japan

Location

Social Medical Corporation Hakuaikai Sagara Hospital

Kagoshima, Japan

Location

St Marianna University School of Medicine Hospital

Kawasaki, Japan

Location

Kyoto University Hospital

Kyoto, Japan

Location

NHO Shikoku Cancer Center

Matsuyama, Japan

Location

Toranomon Hospital

Minato-ku, Tokyo, 105-8470, Japan

Location

Kamiiida Daiichi General Hospital

Nagoya, 463-0802, Japan

Location

Okayama University Hospital

Okayama, Japan

Location

NHO Osaka National Hospital

Ōsaka, Japan

Location

Tohoku University Hospital

Sendai, Japan

Location

National Cancer Center for Global Medicine

Tokyo, Japan

Location

National Cancer Center Hospital

Tokyo, Japan

Location

Showa University Hospital

Tokyo, Japan

Location

St Luke's International Hospital

Tokyo, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, Japan

Location

University of Tsukuba

Tsukuba, Japan

Location

American University of Beirut Medical Center

Beirut, Lebanon

Location

Leiden University Medical Centre, Albinusdreef 2, Postbus 9600

Leiden, 2300 RC, Netherlands

Location

Norwegian Radium Hospital (Oslo University)

Oslo, Norway

Location

Champalimaud Cancer Center - Breast Cancer Unit

Lisbon, Portugal

Location

Institute of Oncology & Radiology of Serbia

Belgrade, Serbia

Location

Institute of Oncology Ljubljana - Medical Oncology Department

Ljubljana, Slovenia

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Hospital Clinico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital General de Catalunya

Barcelona, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, Spain

Location

Instituto Catalán de Oncología de Gerona Hospital

Girona, Spain

Location

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

Madrid, 28050, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Universitario de Fuenlabrada

Madrid, Spain

Location

Hospital Clinico Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Hospital Son Espases, Palma de Mallorca

Palma, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Location

Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Quiron Sagrado Corazon

Seville, Spain

Location

Hospital Virgen De La Salud

Toledo, Spain

Location

Hospital General Universitario de Valencia - Servico Oncologia

Valencia, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Spain

Location

Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

Spital STS AG Onkologiezentrum Thun-Berner Oberland

Thun, Canton of Bern, 3600, Switzerland

Location

Kantonspital Baden AG

Baden, 5404, Switzerland

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Istituto Oncologico della Svizzera Italiana (IOSI)

Bellinzona, Switzerland

Location

Oncocare Bern

Bern, 3012, Switzerland

Location

Brustzentrum Thurgau - Obstetrics and Gynecology

Frauenfeld, Switzerland

Location

University Hospital Geneva

Geneva, 1211, Switzerland

Location

University Hospital of Lausanne (CHUV) BH06 - Oncology Department

Lausanne, Switzerland

Location

Brustzentum Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

CHCVs Hôpital de Sion - Service d'oncologie ambulatoire

Sion, 736, Switzerland

Location

Brust-Zentrum AG

Zurich, 8008, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (8)

  • 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.

    PMID: 19001605BACKGROUND
  • 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.

    PMID: 23768969BACKGROUND
  • 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.

    PMID: 17960621BACKGROUND
  • 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.

    PMID: 18612148BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Olivia Pagani, MD

    Oncology Institue of Southern Switzerland (IOSI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2014

First Posted

December 4, 2014

Study Start

December 4, 2014

Primary Completion

May 15, 2025

Study Completion (Estimated)

December 1, 2028

Last Updated

February 9, 2026

Record last verified: 2026-02

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