Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer
- Conditions
- Early Breast Cancer
- Interventions
- Other: Endocrine therapy interruption
- Registration Number
- NCT02308085
- Lead Sponsor
- ETOP IBCSG Partners Foundation
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 518
- 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.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Endocrine therapy interruption Endocrine therapy interruption Endocrine therapy interruption after having completed between ≥ 18 months and ≤ 30 months.
- Primary Outcome Measures
Name Time Method Breast Cancer free interval (BCFI) From enrollment until the first invasive BC event, assessed up to 14 years Kaplan-Meier Analysis
- Secondary Outcome Measures
Name Time Method Offspring outcome Up to 33 months after enrollment Collect information on preterm birth, low birth weight, births defects rates.
Distant recurrence-free interval (DRFI) Time from enrollment in the study to the first breast cancer recurrence in a distant site, assessed up to 14 years Kaplan-Meier Analysis
Information on Menstruation recovery and pattern Up to 24 months after enrollment Menstrual diary
Pregnancy outcome Up to 33 months after enrollment Labor and delivery Information, full term pregnancy, caesarean section, abortion, miscarriage, ectopic, stillbirth rates.
Pregnancy rate (determined by pregnancy test) Up to 24 months after enrollment Pregnancy test
Breastfeeding pattern Up to 36 months after enrollment Analysis of pattern e.g Duration, use of ipsilateral breast if previous breast conservation, side exclusivity
Use of assisted reproductive Technology (ART) Up to 24 months after enrollment ART use will be tabulated
Trial Locations
- Locations (208)
Mattoon Charleston Primary Care
🇺🇸Mattoon, Illinois, United States
Sanford Bismark Medical Centre
🇺🇸Bismarck, North Dakota, United States
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Emory University
🇺🇸Atlanta, Georgia, United States
John H Stroger Jr Hospital of Cook County
🇺🇸Chicago, Illinois, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
UPMC-Magee Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Cedars Sinai Medical Centre
🇺🇸Los Angeles, California, United States
Poudre Valley Hospital
🇺🇸Fort Collins, Colorado, United States
Smilow Cancer Hospital Care Center at Saint Francis
🇺🇸Hartford, Connecticut, United States
Smilow Cancer Hospital-Orange Care Center
🇺🇸Orange, Connecticut, United States
Smilow Cancer Hospital-Waterbury Care Center
🇺🇸Waterbury, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull
🇺🇸Trumbull, Connecticut, United States
Medical Oncology Hematology Consultants PA
🇺🇸Newport, Delaware, United States
Christiana Care Health System-Christiana Hospital
🇺🇸Newark, Delaware, United States
Regional Hematology Oncology Practice Associates
🇺🇸Newport, Delaware, United States
NorthShore Medical Centre
🇺🇸Skokie, Illinois, United States
IHA Hematology Consultants-Chelsea
🇺🇸Chelsea, Michigan, United States
IHA Hematology Oncology Consultants-Ann Arbor
🇺🇸Ypsilanti, Michigan, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Sanford Clinic North - Bemidji
🇺🇸Bemidji, Minnesota, United States
Montefiore Medical Center - Moses Campus, 111 East 210th Street
🇺🇸Bronx, New York, United States
Sanford Roger Maris Cancer Centre
🇺🇸Fargo, North Dakota, United States
Sanford USD Medical Centre - Sioux Falls
🇺🇸Sioux Falls, South Dakota, United States
Bon Secours Saint Francis Medical Centre
🇺🇸Midlothian, Virginia, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
🇨🇦Montréal, Quebec, Canada
Odette Cancer Centre - Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Azienda Sanitaria di Bolzano
🇮🇹Bolzano, Italy
Salvatore Maugeri Foundation - Medical Oncology Unit
🇮🇹Pavia, Italy
AO Universitaria Ospedale Di Circolo e Fondazione
🇮🇹Varese, Italy
Kansai Rosai Hospital
🇯🇵Amagasaki, Hyogo, Japan
Seirei Hamamatsu General Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Japan
Showa University Hospital
🇯🇵Tokyo, Japan
Hospital General de Catalunya
🇪🇸Barcelona, Spain
Hospital Universitario Donostia
🇪🇸Donostia, Spain
Brustzentum Kantonsspital St. Gallen
🇨🇭St. Gallen, Switzerland
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Med. Univ. Klinik f. Chir
🇦🇹Vienna, Austria
University Hospital Limerick
🇮🇪Limerick, Ireland
Norwegian Radium Hospital (Oslo University)
🇳🇴Oslo, Norway
Institute of Oncology & Radiology of Serbia
🇷🇸Belgrade, Serbia
Institute of Oncology Ljubljana - Medical Oncology Department
🇸🇮Ljubljana, Slovenia
Universitätsspital Basel
🇨🇭Basel, Switzerland
Brustzentrum Thurgau - Obstetrics and Gynecology
🇨🇭Frauenfeld, Switzerland
Brust-Zentrum AG
🇨🇭Zürich, Switzerland
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Bozeman Deaconess Hospital
🇺🇸Bozeman, Montana, United States
St. James's Hospital
🇮🇪Dublin 8, Ireland
Inselspital Bern
🇨🇭Bern, Switzerland
CHCVs Hôpital de Sion - Service d'oncologie ambulatoire
🇨🇭Sion, Switzerland
St Vincent's University Hospital
🇮🇪Dublin, Ireland
University Hospital Zurich
🇨🇭Zurich, Switzerland
Univ. Klinik f. Frauenheilkunde u. Geburtshilfe
🇦🇹Graz, Austria
Hospital Clinico Universitario Virgen de la Arrixaca
🇪🇸El Palmar, Murcia, Spain
Univ. Klinik f. Frauenheilkunde Innsbruck
🇦🇹Innsbruck, Austria
LKH Salzburg
🇦🇹Salzburg, Austria
University Hospital Waterford
🇮🇪Waterford, Ireland
University Hospital of Lausanne (CHUV) BH06 - Oncology Department
🇨🇭Lausanne, Switzerland
Hennepin County Medical Center - Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Huntsman Cancer Institute / University of Utah
🇺🇸Salt Lake City, Utah, United States
SCL Health Saint Joseph Hospital
🇺🇸Denver, Colorado, United States
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
St Marianna University School of Medicine Hospital
🇯🇵Kawasaki, Japan
Spartanburg Medical Center
🇺🇸Spartanburg, South Carolina, United States
Greenville Health System Cancer Institute-Faris
🇺🇸Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Stanford Cancer Institute
🇺🇸Palo Alto, California, United States
Rocky Mountain Cancer Center
🇺🇸Boulder, Colorado, United States
Smilow Cancer Hospital Care Center-Fairfield
🇺🇸Fairfield, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center
🇺🇸North Haven, Connecticut, United States
Smilow Cancer Hospital-Derby Care Center
🇺🇸Derby, Connecticut, United States
Smilow Cancer Hospital-Torrington Care Center
🇺🇸Torrington, Connecticut, United States
Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
🇺🇸Evanston, Illinois, United States
Carle Cancer Centre
🇺🇸Urbana, Illinois, United States
Greater Baltimore Medical Centre
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
The Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
IHA Hematology Consultants-Brighton
🇺🇸Brighton, Michigan, United States
Saint Joseph Mercy Hospital- Canton
🇺🇸Canton, Michigan, United States
IHA Hematology Consultants-Canton
🇺🇸Canton, Michigan, United States
Saint Joseph Mercy Hospital - Chelsea
🇺🇸Chelsea, Michigan, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Saint Joseph Mercy Hospital - Brighton
🇺🇸Brighton, Michigan, United States
Essentia Health Cancer Center
🇺🇸Duluth, Minnesota, United States
St John's Hospital
🇺🇸Maplewood, Minnesota, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Park Nicollet Methodist Hospital
🇺🇸Saint Louis Park, Minnesota, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, United States
Montefiore Medical Center-Weiler Hospital
🇺🇸Bronx, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Sanford Medical Centre
🇺🇸Fargo, North Dakota, United States
Dickstein Cancer Treatment Centre
🇺🇸White Plains, New York, United States
Margaret R Pardee Memorial Hospital
🇺🇸Hendersonville, North Carolina, United States
Chagrin Highlands
🇺🇸Orange Village, Ohio, United States
Southeastern Medical Oncology Centre
🇺🇸Wilson, North Carolina, United States
Greenville Health System Cancer Institute-Butternut
🇺🇸Greenville, South Carolina, United States
Women and Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
Greenville Health System Cancer Institute-Seneca
🇺🇸Seneca, South Carolina, United States
Sanford Cancer Centre Oncology Clinic
🇺🇸Sioux Falls, South Dakota, United States
Doctor's Hospital of Laredo
🇺🇸Laredo, Texas, United States
St John of God Subiaco Hospital
🇦🇺Perth, Western Australia, Australia
University of Vermont Medical Centre
🇺🇸Burlington, Vermont, United States
Bon Secours Memorial Regional Medical Centre
🇺🇸Mechanicsville, Virginia, United States
Cliniques Universitaires Saint-Luc Brussels
🇧🇪Brussels, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Clinique St.Elizabeth
🇧🇪Namur, Belgium
Institut Jules Bordet
🇧🇪Brussels, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Rigshospitalet
🇩🇰København, Denmark
CHA-Hopital Du St-Sacrement
🇨🇦Quebec City, Quebec, Canada
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
C.H.U. Sart-Tilman
🇧🇪Liege, Belgium
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Institut Bergonie
🇫🇷Bordeaux, France
St Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Laso General Hospital, First Department of Medical Oncology
🇬🇷Athens, Greece
Galway University Hospital
🇮🇪Galway, Ireland
Debrecen University Dep. of Oncology
🇭🇺Debrecen, Hungary
APHP, Tenon Hospital in Paris
🇫🇷Paris, France
University General Hospital of Heraklion
🇬🇷Stavrakia, Crete, Greece
French Lyon Cancer Center
🇫🇷Lyon, France
Chaim Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Multimedica Spa
🇮🇹Castellanza, Vareze, Italy
Centro di Riferimento Oncologico
🇮🇹Aviano, Italy
Ospedale di Prato
🇮🇹Prato, Firenze, Italy
Istituto scientifico Romagnolo per lo studio e la cura
🇮🇹Meldola, Italy
U.O Medicina Oncologica Ospedale di Carpi
🇮🇹Carpi, Modena, Italy
Ospedale degli Infermi - S. C. Oncologia Medica
🇮🇹Biella, Italy
Ospedale di Trento
🇮🇹Trento, Italy
Istituto Nazionale Ricerca Cancro
🇮🇹Genova, Italy
Istituto Europeo di Oncologia (IEO)
🇮🇹Milan, Italy
University of Eastern Piedmont
🇮🇹Novara, Italy
UO Oncologia, Rimini Hospital
🇮🇹Rimini, Italy
Ospedale Belcolle di Viterbo
🇮🇹Viterbo, Italy
Regina Elena National Cancer Institute
🇮🇹Rome, Italy
Social Medical Corporation Hakuaikai Sagara Hospital
🇯🇵Kagoshima, Japan
NHO Kyushu Cancer Centre, 3-1-1 Notame Minami-ku Fukuoka-shi
🇯🇵Fukuoka, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
NHO Shikoku Cancer Center
🇯🇵Matsuyama, Japan
Tohoku University Hospital
🇯🇵Sendai, Japan
Toranomon Hospital
🇯🇵Minato-ku, Tokyo, Japan
Kamiiida Daiichi General Hospital
🇯🇵Nagoya, Japan
National Cancer Center for Global Medicine
🇯🇵Tokyo, Japan
St Luke's International Hospital
🇯🇵Tokyo, Japan
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
University of Tsukuba
🇯🇵Tsukuba, Japan
The Cancer Institute Hospital of JFCR
🇯🇵Tokyo, Japan
Leiden University Medical Centre, Albinusdreef 2, Postbus 9600
🇳🇱Leiden, Netherlands
NHO Osaka National Hospital
🇯🇵Ōsaka, Japan
American University of Beirut Medical Center
🇱🇧Beirut, Lebanon
Champalimaud Cancer Center - Breast Cancer Unit
🇵🇹Lisbon, Portugal
Hospital Universitario de Fuenlabrada
🇪🇸Madrid, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario HM Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
🇪🇸Madrid, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Instituto Catalán de Oncología de Gerona Hospital
🇪🇸Gerona, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Clinico Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital General Universitario de Valencia - Servico Oncologia
🇪🇸Valencia, Spain
Hospital Son Espases, Palma de Mallorca
🇪🇸Palma, Spain
Hospital Clinico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Complejo Hospitalario Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
Hospital Quiron Sagrado Corazon
🇪🇸Sevilla, Spain
Spital STS AG Onkologiezentrum Thun-Berner Oberland
🇨🇭Thun, Bern, Switzerland
Hospital Virgen De La Salud
🇪🇸Toledo, Spain
University Hospital Geneva
🇨🇭Genève, Switzerland
Kantonspital Baden AG
🇨🇭Baden, Switzerland
Istituto Oncologico della Svizzera Italiana (IOSI)
🇨🇭Bellinzona, Switzerland
Oncocare Bern
🇨🇭Bern, Switzerland
NorthShore Unversity Health System - Highland Park Hospital
🇺🇸Highland Park, Illinois, United States
Helen F. Graham Cancer Center
🇺🇸Newark, Delaware, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Centre Oscar Lambret
🇫🇷Lille, France
Abbott-Northwestern Hospital, 800 East 28th Street
🇺🇸Minneapolis, Minnesota, United States
NorthShore University Health System - Glenbrook Hospital
🇺🇸Glenview, Illinois, United States
Carle on Vermilion
🇺🇸Danville, Illinois, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Carle Physician Group - Effingham
🇺🇸Effingham, Illinois, United States
Montefiore Medical Center - Einstein Campus, 1695 Eastchester Road
🇺🇸Bronx, New York, United States
University of Colorado Cancer Centre - Anschutz Cancer Pavilion
🇺🇸Aurora, Colorado, 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
Greenville Health System Cancer Institute-Greer
🇺🇸Greer, South Carolina, United States
Greenville Health System Cancer Institute-Eastside
🇺🇸Greenville, South Carolina, United States
Saint Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Yale University - Yale Cancer Centre
🇺🇸New Haven, Connecticut, United States
Bon Secours Saint Mary's Hospital
🇺🇸Richmond, Virginia, United States
UNC Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States