ABCSG 28 / Posytive

Status: Treatment Phase & Follow-up

Primary Operation in SYnchronous meTastasized InVasivE breast cancer, a multicenter prospective randomized study to evaluate the use of local therapy.

Coordinating Investigator: Florian Fitzal (Vienna)
Start of study: 11/2010 (national)
Sample size: 254
Sponsor: ABCSG


Description and status:

The purpose of the POSYTIVE study is to follow the disease progression of patients suffering from metastasized breast cancer where the main tumor is removed by surgery. The control arm of the randomized trial consists of patients where such breast surgery is only carried out on demand, e.g., bleeding or infections have occurred. A total of 90 patients were randomized at 14 centers throughout Austria. The recruitment was stopped prematurely on November 6th, 2015, whereupon all patients transitioned into the 5-year follow-up phase which ended in October 2020. The results of the study could not demonstrate a benefit for patients within the surgery arm in terms of survival, instead the data indicated a trend towards the opposite. These findings were published in 2018 by Florian Fitzal in the journal Annals of Surgery. Another publication by Vesna Bjelic-Radisic on the quality of life of the study participants was published in June 2020 in the British Journal of Cancer. The surveys revealed that the surgery did not alter the quality of life, however reported health status and physical functioning were predictors for the survival of the patients.


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