NCT01015625

Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Austrian Breast & Colorectal Cancer Study Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Synchronous Metastasized Breast Cancer
• Circulating Tumor Cells

Interventions

Type	Name	Description
PROCEDURE	Surgery	lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II)
PROCEDURE	Surgery on Demand	if necessary local therapy on demand

Timeline

• Start date: 2010-11-24
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2009-11-18
• Last updated: 2024-08-19
• Results posted: 2024-08-19

Locations

14 sites across 1 country: Austria