Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer — POSYTIVE  

Circulating Tumor Cells Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Circulating Tumor Cells
• Neoplasm Metastasis
• Neoplastic Cells, Circulating
• Synchronous Metastasized Breast Cancer

• NCT number: NCT01015625
• Study type: Interventional
• Source: Austrian Breast & Colorectal Cancer Study Group
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Completion date: July 2022