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Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer
Sponsor: ETOP IBCSG Partners Foundation
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.
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
Key Details
Gender
FEMALE
Age Range
18 Years - 42 Years
Study Type
INTERVENTIONAL
Enrollment
518
Start Date
2014-12-04
Completion Date
2028-12
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
Endocrine therapy interruption
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.
Locations (211)
Cedars Sinai Medical Centre
Los Angeles, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Sharp Memorial Hospital
San Diego, California, United States
University of Colorado Cancer Centre - Anschutz Cancer Pavilion
Aurora, Colorado, United States
Rocky Mountain Cancer Center
Boulder, Colorado, United States
SCL Health Saint Joseph Hospital
Denver, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Yale University - Yale Cancer Centre
New Haven, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States
Smilow Cancer Hospital-Orange Care Center
Orange, Connecticut, United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States
Helen F. Graham Cancer Center
Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newport, Delaware, United States
Regional Hematology Oncology Practice Associates
Newport, Delaware, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
OnCare Hawaii Inc - POB I
Honolulu, Hawaii, United States
Queen's Medical Centre
Honolulu, Hawaii, United States
OnCare Hawaii-Kuakini
Honolulu, Hawaii, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
Carle on Vermilion
Danville, Illinois, United States
Carle Physician Group - Effingham
Effingham, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Northwestern University
Evanston, Illinois, United States
NorthShore University Health System - Glenbrook Hospital
Glenview, Illinois, United States
NorthShore Unversity Health System - Highland Park Hospital
Highland Park, Illinois, United States
Mattoon Charleston Primary Care
Mattoon, Illinois, United States
NorthShore Medical Centre
Skokie, Illinois, United States
Carle Cancer Centre
Urbana, Illinois, United States
The Carle Foundation Hospital
Urbana, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Greater Baltimore Medical Centre
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
IHA Hematology Consultants-Brighton
Brighton, Michigan, United States
Saint Joseph Mercy Hospital - Brighton
Brighton, Michigan, United States
IHA Hematology Consultants-Canton
Canton, Michigan, United States
Saint Joseph Mercy Hospital- Canton
Canton, Michigan, United States
IHA Hematology Consultants-Chelsea
Chelsea, Michigan, United States
Saint Joseph Mercy Hospital - Chelsea
Chelsea, Michigan, United States
IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan, United States
Sanford Clinic North - Bemidji
Bemidji, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
St John's Hospital
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital, 800 East 28th Street
Minneapolis, Minnesota, United States
Hennepin County Medical Center - Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Park Nicollet Methodist Hospital
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Weill Medical College of Cornell University
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center - Einstein Campus, 1695 Eastchester Road
The Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus, 111 East 210th Street
The Bronx, New York, United States
Dickstein Cancer Treatment Centre
White Plains, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Southeastern Medical Oncology Centre
Clinton, North Carolina, United States
Southeastern Medical Oncology Centre
Goldsboro, North Carolina, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Southeastern Medical Oncology Centre
Jacksonville, North Carolina, United States
Southeastern Medical Oncology Centre
Wilson, North Carolina, United States
Sanford Bismark Medical Centre
Bismarck, North Dakota, United States
Sanford Roger Maris Cancer Centre
Fargo, North Dakota, United States
Sanford Medical Centre
Fargo, North Dakota, United States
Case Western Reserve University
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Chagrin Highlands
Orange, Ohio, United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States
Sanford Cancer Centre Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Centre - Sioux Falls
Sioux Falls, South Dakota, United States
Doctor's Hospital of Laredo
Laredo, Texas, United States
Huntsman Cancer Institute / University of Utah
Salt Lake City, Utah, United States
University of Vermont Medical Centre
Burlington, Vermont, United States
Bon Secours Memorial Regional Medical Centre
Mechanicsville, Virginia, United States
Bon Secours Saint Francis Medical Centre
Midlothian, Virginia, United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
St John of God Subiaco Hospital
Perth, Western Australia, Australia
Univ. Klinik f. Frauenheilkunde u. Geburtshilfe
Graz, Austria
Univ. Klinik f. Frauenheilkunde Innsbruck
Innsbruck, Austria
LKH Salzburg
Salzburg, Austria
Med. Univ. Klinik f. Chir
Vienna, Austria
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Cliniques Universitaires Saint-Luc Brussels
Brussels, Belgium
Institut Jules Bordet
Brussels, Belgium
UZ Leuven
Leuven, Belgium
C.H.U. Sart-Tilman
Liège, Belgium
Clinique St.Elizabeth
Namur, Belgium
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Vancouver Cancer Centre
Vancouver, British Columbia, Canada
St Michael's Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Odette Cancer Centre - Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
CHA-Hopital Du St-Sacrement
Québec, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Rigshospitalet
Copenhagen, Denmark
Institut Bergonie
Bordeaux, France
Centre Oscar Lambret
Lille, France
French Lyon Cancer Center
Lyon, France
APHP, Tenon Hospital in Paris
Paris, France
University General Hospital of Heraklion
Stavrakia, Crete, Greece
Laso General Hospital, First Department of Medical Oncology
Athens, Greece
Debrecen University Dep. of Oncology
Debrecen, Hungary
St Vincent's University Hospital
Dublin, Ireland
St. James's Hospital
Dublin, Ireland
Galway University Hospital
Galway, Ireland
University Hospital Limerick
Limerick, Ireland
University Hospital Waterford
Waterford, Ireland
Shaare Zedek Medical Center
Jerusalem, Israel
Chaim Sheba Medical Center
Tel Litwinsky, Israel
Ospedale di Prato
Prato, Firenze, Italy
U.O Medicina Oncologica Ospedale di Carpi
Carpi, Modena, Italy
Ospedale di Trento
Trento, Trento, Italy
Multimedica Spa
Castellanza, Vareze, Italy
Centro di Riferimento Oncologico
Aviano, Italy
Ospedale degli Infermi - S. C. Oncologia Medica
Biella, Italy
Azienda Sanitaria di Bolzano
Bolzano, Italy
Istituto Nazionale Ricerca Cancro
Genova, Italy
Istituto scientifico Romagnolo per lo studio e la cura
Meldola, Italy
Istituto Europeo di Oncologia (IEO)
Milan, Italy
University of Eastern Piedmont
Novara, Italy
Salvatore Maugeri Foundation - Medical Oncology Unit
Pavia, Italy
UO Oncologia, Rimini Hospital
Rimini, Italy
Regina Elena National Cancer Institute
Rome, Italy
AO Universitaria Ospedale Di Circolo e Fondazione
Varese, Italy
Ospedale Belcolle di Viterbo
Viterbo, Italy
Kansai Rosai Hospital
Amagasaki, Hyōgo, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
NHO Kyushu Cancer Centre, 3-1-1 Notame Minami-ku Fukuoka-shi
Fukuoka, Japan
Social Medical Corporation Hakuaikai Sagara Hospital
Kagoshima, Japan
St Marianna University School of Medicine Hospital
Kawasaki, Japan
Kyoto University Hospital
Kyoto, Japan
NHO Shikoku Cancer Center
Matsuyama, Japan
Toranomon Hospital
Minato-ku, Tokyo, Japan
Kamiiida Daiichi General Hospital
Nagoya, Japan
Okayama University Hospital
Okayama, Japan
NHO Osaka National Hospital
Ōsaka, Japan
Tohoku University Hospital
Sendai, Japan
National Cancer Center for Global Medicine
Tokyo, Japan
National Cancer Center Hospital
Tokyo, Japan
Showa University Hospital
Tokyo, Japan
St Luke's International Hospital
Tokyo, Japan
The Cancer Institute Hospital of JFCR
Tokyo, Japan
University of Tsukuba
Tsukuba, Japan
American University of Beirut Medical Center
Beirut, Lebanon
Leiden University Medical Centre, Albinusdreef 2, Postbus 9600
Leiden, Netherlands
Norwegian Radium Hospital (Oslo University)
Oslo, Norway
Champalimaud Cancer Center - Breast Cancer Unit
Lisbon, Portugal
Institute of Oncology & Radiology of Serbia
Belgrade, Serbia
Institute of Oncology Ljubljana - Medical Oncology Department
Ljubljana, Slovenia
Samsung Medical Center
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital General de Catalunya
Barcelona, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Spain
Instituto Catalán de Oncología de Gerona Hospital
Girona, Spain
Hospital Universitario HM Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario de Fuenlabrada
Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Son Espases, Palma de Mallorca
Palma, Spain
Complejo Hospitalario de Navarra
Pamplona, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain
Universitario Virgen del Rocio
Seville, Spain
Hospital Quiron Sagrado Corazon
Seville, Spain
Hospital Virgen De La Salud
Toledo, Spain
Hospital General Universitario de Valencia - Servico Oncologia
Valencia, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain
Inselspital Bern
Bern, Canton of Bern, Switzerland
Spital STS AG Onkologiezentrum Thun-Berner Oberland
Thun, Canton of Bern, Switzerland
Kantonspital Baden AG
Baden, Switzerland
Universitätsspital Basel
Basel, Switzerland
Istituto Oncologico della Svizzera Italiana (IOSI)
Bellinzona, Switzerland
Oncocare Bern
Bern, Switzerland
Brustzentrum Thurgau - Obstetrics and Gynecology
Frauenfeld, Switzerland
University Hospital Geneva
Geneva, Switzerland
University Hospital of Lausanne (CHUV) BH06 - Oncology Department
Lausanne, Switzerland
Brustzentum Kantonsspital St. Gallen
Sankt Gallen, Switzerland
CHCVs Hôpital de Sion - Service d'oncologie ambulatoire
Sion, Switzerland
Brust-Zentrum AG
Zurich, Switzerland
University Hospital Zurich
Zurich, Switzerland