Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer, a Multicenter Prospective Randomized Study to Evaluate the Use of Local Therapy
This study is a prospective, randomized, multicentre, study concerning the influence of
local treatment on the patients with synchronous metastasized breast cancer. Patients will
be stratified at inclusion according to the centre, the menopausal status (pre-menopausal,
post-menopausal), the hormone-receptor status (ER-/PR-/not determinable; any PR and/or Er+),
the HER-2 status (positive vs. negative/not determinable), the grading (G1/G2/not
determinable vs. G3), location of metastases (visceral ± vs bone only), organs with
metastases (single organ vs multiple organs) and use of first line chemotherapy
(anthracycline ± vs. taxane vs others). Thereafter patients will be randomly assigned to
receive either local therapy of the breast (lumpectomy or mastectomy + axillary surgery /±
radiotherapy) versus no local therapy. Systemic therapy will be administered at the centers
policy.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
to evaluate the median survival of patients with synchronous metastasized breast cancer and the primary tumor in place comparing arm A with local therapy to the primary tumor versus arm B without local therapy
time point at which 50% of all randomized patient died
No
Florian Fitzal, MD
Study Director
Austrian Breast & Colorectal Cancer Study Group
Austria: Agency for Health and Food Safety
ABCSG 28 / POSYTIVE
NCT01015625
May 2010
May 2019
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