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Brief Title: Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer
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
Study ID: 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.
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.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
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, District of Columbia, United States
Sibley Memorial Hospital, Washington, 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, Saint 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
Montefiore Medical Center - Einstein Campus, 1695 Eastchester Road, Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital, Bronx, New York, United States
Montefiore Medical Center - Moses Campus, 111 East 210th Street, Bronx, New York, United States
Weill Medical College of Cornell University, New York, New York, United States
SUNY Upstate Medical University, Syracuse, 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 Village, 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, Liege, , 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, Montréal, Quebec, Canada
CHA-Hopital Du St-Sacrement, Quebec City, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
Rigshospitalet, København, , 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. James's Hospital, Dublin 8, , Ireland
St Vincent's University 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 Hashomer, , Israel
Ospedale di Prato, Prato, Firenze, Italy
U.O Medicina Oncologica Ospedale di Carpi, Carpi, Modena, 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
Ospedale di Trento, Trento, , Italy
AO Universitaria Ospedale Di Circolo e Fondazione, Varese, , Italy
Ospedale Belcolle di Viterbo, Viterbo, , Italy
Kansai Rosai Hospital, Amagasaki, Hyogo, 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
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
NHO Osaka National Hospital, Ōsaka, , Japan
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
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
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, , Spain
Instituto Catalán de Oncología de Gerona Hospital, Gerona, , 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, Sevilla, , Spain
Hospital Quiron Sagrado Corazon, Sevilla, , Spain
Hospital Virgen De La Salud, Toledo, , Spain
Hospital General Universitario de Valencia - Servico Oncologia, Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa, Zaragoza, , Spain
Spital STS AG Onkologiezentrum Thun-Berner Oberland, Thun, Bern, Switzerland
Kantonspital Baden AG, Baden, , Switzerland
Universitätsspital Basel, Basel, , Switzerland
Istituto Oncologico della Svizzera Italiana (IOSI), Bellinzona, , Switzerland
Inselspital Bern, Bern, , Switzerland
Oncocare Bern, Bern, , Switzerland
Brustzentrum Thurgau - Obstetrics and Gynecology, Frauenfeld, , Switzerland
University Hospital Geneva, Genève, , Switzerland
University Hospital of Lausanne (CHUV) BH06 - Oncology Department, Lausanne, , Switzerland
CHCVs Hôpital de Sion - Service d'oncologie ambulatoire, Sion, , Switzerland
Brustzentum Kantonsspital St. Gallen, St. Gallen, , Switzerland
University Hospital Zurich, Zurich, , Switzerland
Brust-Zentrum AG, Zürich, , Switzerland
Name: Olivia Pagani, MD
Affiliation: Oncology Institue of Southern Switzerland (IOSI)
Role: STUDY_CHAIR