Spots Global Cancer Trial Database for Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer

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Trial Identification

Brief Title: Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer

Official Title: Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer, a Multicenter Prospective Randomized Study to Evaluate the Use of Local Therapy

Study ID: NCT01015625

Conditions

Synchronous Metastasized Breast Cancer

Circulating Tumor Cells

Interventions

Surgery

Surgery on Demand

Study Description

Brief Summary: Primary Operation in synchronous metastasized invasive breast cancer to evaluate the use of local therapy

Detailed Description: 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.