Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer
NCT ID: NCT01015625
Last Updated: 2024-08-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2010-11-24
2022-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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A: Surgical Therapy
Local therapy consists of lumpectomy or mastectomy with or without radiotherapy (according to center tumor board decision) with a resection free margin of at least 1 mm or more demonstrated on paraffin embedded histological sections. Intraoperative frozen sections are allowed but not definitive for margin assessment. Sentinel node biopsy may be performed and has always to be followed by axillary dissection of level I and II (axillary surgery level I and II is mandatory).
Surgery
lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II)
B: Surgery on Demand
In Arm B (no local therapy) it may be necessary to perform local therapy on demand (surgery, radiotherapy). Reasons may be uncontrolled bleeding or infected exulcerations with a septic component and no treatment benefit from conservative therapy. This will be considered as protocol deviation. However, the patient's follow up is recorded and data are available for analyses as intention to treat.
Surgery on Demand
if necessary local therapy on demand
Interventions
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Surgery
lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II)
Surgery on Demand
if necessary local therapy on demand
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Amgen
INDUSTRY
Hoffmann-La Roche
INDUSTRY
AstraZeneca
INDUSTRY
Sanofi
INDUSTRY
Wyeth-Lederle Pharma GmbH
INDUSTRY
GlaxoSmithKline
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Fond of the Viennese Mayor
OTHER
Austrian Breast & Colorectal Cancer Study Group
NETWORK
Responsible Party
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Principal Investigators
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Florian Fitzal, MD
Role: STUDY_DIRECTOR
Austrian Breast & Colorectal Cancer Study Group
Michael Gnant, MD
Role: STUDY_DIRECTOR
Austrian Breast & Colorectal Cancer Study Group
Guenther Steger, MD
Role: STUDY_DIRECTOR
Austrian Breast & Colorectal Cancer Study Group
Locations
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Hospital Guessing
Güssing, Burgenland, Austria
Hospital Oberpullendorf
Oberpullendorf, Burgenland, Austria
Ordination Dr. Wette
Saint Veit A. D. Glan, Carinthia, Austria
Gynaegological Medical University Graz
Graz, Styria, Austria
Medical University Graz, Oncology
Graz, Styria, Austria
Medical University of Innsbruck
Innsbruck, Tyrol, Austria
Ordensklinikum Linz GmbH - BHS Linz, Coop. Study Group
Linz, Upper Austria, Austria
Ordensklinikum Linz GmbH - Elisabethinen Linz
Linz, Upper Austria, Austria
General Hospital Linz
Linz, Upper Austria, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Upper Austria, Austria
State Hospital Feldkirch
Feldkirch, Vorarlberg, Austria
Paracelsus Medical University Salzburg-Oncology, Coop. Group
Salzburg, , Austria
Medical University of Vienna-General Hospital Vienna
Vienna, , Austria
Medical University of Vienna
Vienna, , Austria
Countries
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References
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ABCSG 28
Identifier Type: OTHER
Identifier Source: secondary_id
ABCSG 28 / POSYTIVE
Identifier Type: -
Identifier Source: org_study_id
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