Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Neoplastic Cells, Circulating

Breast Diseases

Skin Diseases

Neoplastic Processes

All Drugs and Chemicals

Mitogens

Local therapy consists of lumpectomy or mastectomy with or without radiotherapy (according to center tumor board decision) with a resection free margin of at least 1 mm or more demonstrated on paraffin embedded histological sections. Intraoperative frozen sections are allowed but not definitive for margin assessment. Sentinel node biopsy may be performed and has always to be followed by axillary dissection of level I and II (axillary surgery level I and II is mandatory).

In Arm B (no local therapy) it may be necessary to perform local therapy on demand (surgery, radiotherapy). Reasons may be uncontrolled bleeding or infected exulcerations with a septic component and no treatment benefit from conservative therapy. This will be considered as protocol deviation. However, the patient's follow up is recorded and data are available for analyses as intention to treat.

lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II)

Surgery

Surgery on Demand

Florian Fitzal, MD

Michael Gnant, MD

Guenther Steger, MD

Primary Operation in synchronous metastasized invasive breast cancer 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer	NCT01015625	Synchronous Met... Circulating Tum...	Surgery Surgery on Dema...	18 Years -	Austrian Breast & Colorectal Cancer Study Group
Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer	NCT01015625	Synchronous Met... Circulating Tum...	Surgery Surgery on Dema...	18 Years -	Austrian Breast & Colorectal Cancer Study Group

Spots Global Cancer Trial Database for surgery on demand