Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer
Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer
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