ABCSG 48 / POSITIVE
Status: Treatment Phase & Follow-up
A study evaluating the pregnancy outcomes and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer who desire pregnancy (POSITIVE)
|Coordinating Investigator:||Vesna Bjelic-Radisic (Graz/Wuppertal)|
|Start of study:||12/2014 (global), 04/2018 (national)|
|Sponsor:||ETOP IBCSG Partners Foundation|
Description and status:
For the first time in a clinical trial setting (and in Austria), it is being examined whether an interruption of endocrine breast cancer therapy is possible without disadvantages for the patient in order to pursue the wish to become pregnant. The study is led by the International Breast Cancer Study Group (ETOP IBCSG Partners Foundation) with a total of 20 countries involved, such as the US, Canada, the Netherlands, Ireland, Greece and Austria, among others. Four ABCSG sites, namely centers in Graz, Salzburg, Vienna, and Innsbruck are participating in this trial. 518 patients were enrolled, thereof seven in Austria. First results show that the rates of breast cancer recurrence were similar to women who did not interrupt their treatment. With a total of 368 women having at least one pregnancy and 365 babies born (six in Austria) the rates of conception and childbirth were similar to or higher than rates in the general population. Long-term follow-up is planned to confirm long-term safety.
Data collected in the trial are of high relevance to all physicians, as they are often confronted with the patients’ wish to become pregnant, yet without any evidence-based information for that setting being available so far.