Clinical Trial

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

Study acronym: POSITIVE
Active, Not Recruiting
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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.
Protocol Amendment History 24 amendments
This ClinicalTrials.gov record has been amended 24 times since 2014-12-02; most recent amendment 2026-02-05.
Status change: Recruiting → Active, Not Recruiting 2020-03-17
Status change: Not Yet Recruiting → Recruiting 2015-02-13
Trial Details
NCT Number NCT02308085
Lead Sponsor ETOP IBCSG Partners Foundation
Collaborators: Alliance for Clinical Trials in Oncology, Canadian Cancer Trials Group, Breast International Group
Conditions Early Breast Cancer
Enrollment 518 participants
Start Date 2014-12-04
Primary Completion 2025-05-15 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-09