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

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.

Inclusion Criteria:

• Patients age ≥ 18 years
• Eastern Cooperative Oncology Group Performance Status is 0 -2
• Untreated synchronous metastasized invasive carcinoma of the breast with the primary tumor in situ (bilateral synchronous metastasized breast cancer patients are eligible)
• The primary tumor must be identified and may be any size, however, primary resection with resection free margins must be possible
• Invasive adenocarcinoma of the breast on histological examination
• The metastatic site must be identified by radiological assessment(Computer Tomography of the chest and the abdomen OR ultrasound and chest x ray for visceral metastases; bone scan AND/OR computer tomography AND/OR magnetic resonance for bone metastases). A biopsy is not necessary.
• Written informed consent must be obtained and documented prior to beginning any protocol specific procedures and according to local regulatory requirements
• able to comply with the protocol requirements during the treatment and follow-up period.

Exclusion Criteria:

• Patients in whom a R0 resection (microscopic free margins) is clinically questionable
• Inflammatory cancer
• Patients with a brain metastasis
• Patients who are not eligible for general anesthesia and operations
• Patients without metastatic breast cancer (patients with a tumor marker value (CEA, CA15-3) above normal levels without the radiological proven evidence of metastases are not eligible for the study)
• Patients with a second untreated malignancy
• Any previous malignancy treated with curative intent and the patient has not been disease-free for 5 years - exceptions are: (a)carcinoma in situ of the cervix, (b)squamous carcinoma of the skin, (c)basal cell carcinoma of the skin
• Patients with any recurrent cancer disease
• Pregnant or lactating women
• Patients are not allowed to be part of another local therapy trial