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Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer | Clinical Trials | Clareo Health

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Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer

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

NCT01015625•Austrian Breast & Colorectal Cancer Study Group

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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 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)

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

Key Dates

Start Date

November 24, 2010

Primary Completion Date

July 1, 2022

Completion Date

July 1, 2022

Last Updated

August 19, 2024

Enrollment

ACTUAL participants

Conditions

Synchronous Metastasized Breast CancerCirculating Tumor Cells

Interventions

Surgery

PROCEDURE

Surgery on Demand

PROCEDURE

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COMPLETEDEARLY_PHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer

Inclusion Criteria

Exclusion Criteria

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