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Spots Global Cancer Trial Database for Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Olivia Pagani, MD

Affiliation: Oncology Institue of Southern Switzerland (IOSI)

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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