Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer (NCT01015625) | Clinical Trial Compass
CompletedNot Applicable
Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer
Austria90 participantsStarted 2010-11-24
Plain-language summary
Primary Operation in synchronous metastasized invasive breast cancer to evaluate the use of local therapy
Who can participate
Age range18 Years
SexFEMALE
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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 malignanc…
What they're measuring
1
Overall Survival (OS)
Timeframe: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months
Trial details
NCT IDNCT01015625
SponsorAustrian Breast & Colorectal Cancer Study Group