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POSITIVE (IBCSG 48-14/BIG 8-13) – More than 100 patients already enrolled

Intro text: 

The international and purely academic POSITIVE study has already recruited more than 100 patients from 113 activated hospitals and cancer centres. The study, which was set to evaluate the pregnancy outcomes and safety of interrupting endocrine therapy for young women with hormone receptor positive early-stage breast cancer who wish to become pregnant, is now being conducted in 15 different countries (more countries will be activated soon). Overall, POSITIVE aims to recruit 500 patients from centres worldwide in approximately 4 years.

Fertility issues are extremely important to young women affected by breast cancer. Indeed these patients may not have time to wait for 5-10 years of treatment completion before considering pregnancy, and medical oncologists are often confronted with the following question in their daily practice: is it safe for their patients to temporarily interrupt their endocrine treatment to permit pregnancy? The best available evidence suggests that pregnancy after breast cancer does not negatively impact disease outcome and is safe for the offspring but no definitive information is currently available to recommend a safe interval from breast cancer diagnosis to pregnancy.

The POSITIVE trial will investigate endocrine therapy (ET) interruption to enable conception for young women between 18 and 42 years of age with hormone receptor positive early-stage breast cancer who received adjuvant ET for 18 to 30 months and wish to attempt pregnancy.

This trial is a unique opportunity to gather definitive and prospective research data regarding the safety of pregnancy after breast cancer, something that is currently missing. It will also allow researchers to test biologic correlates of pregnancy and disease outcome.

POSITIVE is being conducted and sponsored by the International Breast Cancer Study Group (IBCSG) under the umbrella of the Breast International Group (BIG).

 

The Trial Scheme: 

- Patients with ER+ early breast cancer
- ≤42 years at enrolment
- Completing 18-30 months of ET (SERMs alone, LH-RH analogue + SERM or AIs) 
- Pregnancy desire

For more information about POSITIVE: http://www.ibcsg.org
ClinicalTrials.gov NCT02308085