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

18 Years
Open (Enrolling)
Synchronous Metastasized Breast Cancer, Circulating Tumor Cells

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Trial Information

Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer, a Multicenter Prospective Randomized Study 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

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

- 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

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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

to evaluate the median survival of patients with synchronous metastasized breast cancer and the primary tumor in place comparing arm A with local therapy to the primary tumor versus arm B without local therapy

Outcome Time Frame:

time point at which 50% of all randomized patient died

Safety Issue:


Principal Investigator

Florian Fitzal, MD

Investigator Role:

Study Director

Investigator Affiliation:

Austrian Breast & Colorectal Cancer Study Group


Austria: Agency for Health and Food Safety

Study ID:




Start Date:

May 2010

Completion Date:

May 2019

Related Keywords:

  • Synchronous Metastasized Breast Cancer
  • Circulating Tumor Cells
  • breast cancer
  • growth factor
  • median survival
  • surgery on demand
  • surgical therapy
  • blood specimen
  • tissue specimen
  • VEGF
  • TGF
  • circulating tumor cells
  • stem cells
  • Breast Neoplasms
  • Neoplastic Cells, Circulating
  • Neoplasm Metastasis