Last updated on June 2019

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


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02308085

Find a site near you

Start Over

Spartanburg Medical Center

Spartanburg, SC United States
  Connect »

Toranomon Hospital

Minato-ku, Tokyo, Japan
  Connect »

UPMC-Magee Womens Hospital

Pittsburgh, PA United States
  Connect »

Sibley Memorial Hospital

Washington, WA United States
  Connect »

NorthShore Medical Centre

Skokie, IL United States
  Connect »

Saint Joseph Mercy Hospital

Ann Arbor, MI United States
  Connect »

Missouri Baptist Medical Center

Saint Louis, MO United States
  Connect »

Rigshospitalet

København, Denmark
  Connect »

Northwestern University

Evanston, IL United States
  Connect »

Mercy Hospital

Coon Rapids, MN United States
  Connect »

Cedars Sinai Medical Centre

Los Angeles, CA United States
  Connect »

Indiana University

Indianapolis, IN United States
  Connect »

Stanford Cancer Institute

Palo Alto, CA United States
  Connect »

Mayo Clinic

Rochester, MN United States
  Connect »

Women and Infants Hospital

Providence, RI United States
  Connect »

Poudre Valley Hospital

Fort Collins, CO United States
  Connect »

Georgetown University Hospital

Washington, WA United States
  Connect »

Emory University

Atlanta, GA United States
  Connect »

Straub Clinic and Hospital

Honolulu, HI United States
  Connect »

OnCare Hawaii Inc - POB I

Honolulu, HI United States
  Connect »

Queen's Medical Centre

Honolulu, HI United States
  Connect »

OnCare Hawaii-Kuakini

Honolulu, HI United States
  Connect »

Carle on Vermilion

Danville, IL United States
  Connect »

Carle Cancer Centre

Urbana, IL United States
  Connect »

Johns Hopkins University

Baltimore, MD United States
  Connect »

St John's Hospital

Maplewood, MN United States
  Connect »

Park Nicollet Methodist Hospital

Saint Louis Park, MN United States
  Connect »

Regions Hospital

Saint Paul, MN United States
  Connect »

Bozeman Deaconess Hospital

Bozeman, MT United States
  Connect »

Dickstein Cancer Treatment Centre

White Plains, NY United States
  Connect »

Sanford Medical Centre

Fargo, ND United States
  Connect »

Ohio State University

Columbus, OH United States
  Connect »

Chagrin Highlands

Orange Village, OH United States
  Connect »

LKH Salzburg

Salzburg, Austria
  Connect »

UZ Leuven

Leuven, Belgium
  Connect »

Rigshospitalet

København, Denmark
  Connect »

Multimedica Spa

Castellanza, Italy
  Connect »

Rigshospitalet

København, Denmark
  Connect »

Rigshospitalet

København, Denmark
  Connect »

Rigshospitalet

København, Denmark
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.