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ACTIVE NOT RECRUITING

NCT02308085

Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer

Sponsor: ETOP IBCSG Partners Foundation

View on ClinicalTrials.gov

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

Conditions

Early Breast Cancer

Interventions

OTHER

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.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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

And 111 more locations on ClinicalTrials.gov

Clinical Research Directory

Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (211)