NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer

NCT01015625

CompletedNA

Sponsor: Austrian Breast & Colorectal Cancer Study Group

Conditions: Synchronous Metastasized Breast Cancer, Circulating Tumor Cells

Interventions: Surgery, Surgery on Demand

Countries: Austria

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

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (14)

Guessing, Burgenland, Austria
Oberpullendorf, Burgenland, Austria
Saint Veit A. D. Glan, Carinthia, Austria
Graz, Styria, Austria
Graz, Styria, Austria
Innsbruck, Tyrol, Austria
Linz, Upper Austria, Austria
Linz, Upper Austria, Austria
Linz, Upper Austria, Austria
Wels, Upper Austria, Austria
Feldkirch, Vorarlberg, Austria
Salzburg, Austria
Vienna, Austria
Vienna, Austria