Clinical trial NCT01015625: Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer
Official title: Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer, a Multicenter Prospective Randomized Study to Evaluate the Use of Local Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Synchronous Metastasized Breast Cancer
Circulating Tumor Cells
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
Lead sponsor: Austrian Breast & Colorectal Cancer Study Group
Sponsor class: NETWORK
Collaborators: name: Bayer
name: Amgen
name: Hoffmann-La Roche
name: AstraZeneca
name: Sanofi
name: Wyeth-Lederle Pharma GmbH
name: GlaxoSmithKline
name: Merck Sharp & Dohme LLC
name: Fond of the Viennese Mayor
First posted: 2009-11-18
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Primary Operation in synchronous metastasized invasive breast cancer to evaluate the use of local therapy

Detailed description: 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months
Secondary outcomes:
measure: Time to Distant Progression
timeFrame: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months
measure: Time to Local Progression (TTPl)
timeFrame: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months
Other outcomes:
Locations:
city: Guessing
country: Austria
facility: Hospital Guessing
state: Burgenland
city: Oberpullendorf
country: Austria
facility: Hospital Oberpullendorf
state: Burgenland
city: St. Veit a. d. Glan
country: Austria
facility: Ordination Dr. Wette
state: Carinthia
city: Graz
country: Austria
facility: Gynaegological Medical University Graz
state: Styria
city: Graz
country: Austria
facility: Medical University Graz, Oncology
state: Styria
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
state: Tyrol
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH - BHS Linz, Coop. Study Group
state: Upper Austria
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH - Elisabethinen Linz
state: Upper Austria
city: Linz
country: Austria
facility: General Hospital Linz
state: Upper Austria
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
state: Upper Austria
city: Feldkirch
country: Austria
facility: State Hospital Feldkirch
state: Vorarlberg
city: Salzburg
country: Austria
facility: Paracelsus Medical University Salzburg-Oncology, Coop. Group
city: Vienna
country: Austria
facility: Medical University of Vienna-General Hospital Vienna
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Florian Fitzal, MD
role: STUDY_DIRECTOR
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Michael Gnant, MD
role: STUDY_DIRECTOR
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Guenther Steger, MD
role: STUDY_DIRECTOR
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