primary operation in synchronous metastasized invasive breast cancer

Conditions: Synchronous Metastasized Breast Cancer; Circulating Tumor Cells

Summary: 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.

Eligibility criteria:
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

Keywords: breast cancer abcsg posytive growth factor median survival surgery on demand surgical therapy blood specimen tissue specimen vegf tgf circulating tumor cells stem cells