Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer (POSYTIVE)

This study is currently recruiting participants.

Verified February 2013 by Austrian Breast & Colorectal Cancer Study Group

Sponsor:

Collaborators:

Bayer

Amgen

Hoffmann-La Roche

AstraZeneca

Sanofi Aventis GmbH, Austria

Wyeth Lederle Pharma GmbH, Austria

GlaxoSmithKline

Merck Sharp & Dohme GmbH, Austria

Fond of the Viennese Mayor

Information provided by (Responsible Party):

Austrian Breast & Colorectal Cancer Study Group

ClinicalTrials.gov Identifier:

NCT01015625

First received: November 17, 2009

Last updated: February 28, 2013

Last verified: February 2013

History of Changes

Purpose

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

Condition	Intervention
Synchronous Metastasized Breast Cancer Circulating Tumor Cells	Procedure: Surgery Procedure: Surgery on Demand

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer, a Multicenter Prospective Randomized Study to Evaluate the Use of Local Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:

Primary Outcome Measures:

to evaluate the median survival of patients with synchronous metastasized breast cancer and the primary tumor in place comparing arm A with local therapy to the primary tumor versus arm B without local therapy [ Time Frame: time point at which 50% of all randomized patient died ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

time to distant progression (TTPd) [ Time Frame: Time to treatment change due to systemic progression ] [ Designated as safety issue: No ]
time to local progression (TTPl) [ Time Frame: Increase in size >25% of the primary tumor in arm B (no local therapy). Local recurrence in arm A (local therapy). ] [ Designated as safety issue: No ]

Estimated Enrollment:	254
Study Start Date:	May 2010
Estimated Study Completion Date:	May 2019
Estimated Primary Completion Date:	May 2019 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).	Procedure: 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.	Procedure: Surgery on Demand if necessary local therapy on demand

Arms

Assigned Interventions

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).

Procedure: 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.

Procedure: Surgery on Demand

if necessary local therapy on demand

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015625

Contacts

Contact: Florian Fitzal, MD	+43-1-40400 ext 5621	florian.fitzal@meduniwien.ac.at
Contact: Michael Gnant, MD	+43-1-40400 ext 5646	michael.gnant@meduniwien.ac.at

Locations

Austria
Hospital Guessing	Recruiting
Guessing, Burgenland, Austria, 7540
Contact: Wilfried Horvath, MD, Head +43-5-7979 ext 31251 wilfried.horvath@krages.at
Principal Investigator: Wilfried Horvath, MD, Head
Hospital Oberpullendorf	Recruiting
Oberpullendorf, Burgenland, Austria, 7350
Contact: Ursula Swoboda, MD +43-05-7979 ext 34893 ursula.swoboda@krages.at
Principal Investigator: Ursula Swoboda, MD
Ordination Dr. Wette	Recruiting
St. Veit a. d. Glan, Carinthia, Austria, 9300
Contact: Viktor Wette, MD +43-4212-33222
Principal Investigator: Viktor Wette, MD
Medical University Graz, Oncology	Recruiting
Graz, Styria, Austria, 8036
Contact: Hellmut Samonigg, MD +43-316-385 ext 13112 hellmut.samonigg@klinikum-graz.at
Principal Investigator: Hellmut Samonigg, MD
Gynaegological Medical University Graz	Recruiting
Graz, Styria, Austria, 8036
Contact: Vesna Bjelic-Radisic, MD +43-316-385 ext 80504 vesna.bjelic-radisic@medunigraz.at
Principal Investigator: Vesna Bjelic-Radisic, MD
Medical University of Innsbruck	Recruiting
Innsbruck, Tyrol, Austria, 6020
Contact: Michael Hubalek, MD +43-512-504 ext 81285 michael.hubalek@i-med.ac.at
Principal Investigator: Michael Hubalek, MD
General Hospital Linz	Recruiting
Linz, Upper Austria, Austria, 4020
Contact: Peter Schrenk, MD +43-732-7806 ext 3170 peter.schrenk@akh.linz.at
Principal Investigator: Peter Schrenk, MD
Hospital BHS Linz, Coop. Study Group	Recruiting
Linz, Upper Austria, Austria, 4010
Contact: Dietmar Heck, MD +43-732-7677 dietmar.heck@bhs.at
Principal Investigator: Dietmar Heck, MD
Hospital Elisabethinen Linz	Recruiting
Linz, Upper Austria, Austria, 4010
Contact: Reinhold Fuegger, MD, Head +43-732-7676 ext 4700 reinhold.fuegger@elisabethinen.or.at
Principal Investigator: Reinhold Fuegger, MD
Klinikum Wels-Grieskirchen GmbH	Recruiting
Wels, Upper Austria, Austria, 4600
Contact: Josef Thaler, MD, Head +43+7242-415 ext 93450 josef.thaler@klinikum-wegr.at
Principal Investigator: Josef Thaler, MD
State Hospital Feldkirch	Recruiting
Feldkirch, Vorarlberg, Austria, 6807
Contact: Anton Haid, MD +43-5522-303 ext 2400 anton.haid@lkhf.at
Principal Investigator: Anton Haid, MD
Paracelsus Medical University Salzburg-Oncology, Coop. Group	Recruiting
Salzburg, Austria, 5020
Contact: Richard Greil, MD +43-662-4482 ext 2880 r.greil@salk.at
Principal Investigator: Richard Greil, MD
Medical University of Vienna	Recruiting
Vienna, Austria, 1090
Contact: Christian Singer, MD, MPH +43-1-40400 ext 2801 christian.singer@meduniwien.ac.at
Principal Investigator: Christian Singer, MD, MPH
Medical University of Vienna-General Hospital Vienna	Recruiting
Vienna, Austria, 1090
Contact: Florian Fitzal, MD +43-1-40400 ext 5621 florian.fitzal@meduniwien.ac.at
Contact: Michael Gnant, MD +43-1-40400 ext 5646 michael.gnant@meduniwien.ac.at
Principal Investigator: Florian Fitzal, MD

Sponsors and Collaborators

Austrian Breast & Colorectal Cancer Study Group

Bayer

Amgen

Hoffmann-La Roche

AstraZeneca

Sanofi Aventis GmbH, Austria

Wyeth Lederle Pharma GmbH, Austria

GlaxoSmithKline

Merck Sharp & Dohme GmbH, Austria

Fond of the Viennese Mayor

Investigators

Study Director:	Florian Fitzal, MD	Austrian Breast & Colorectal Cancer Study Group
Study Director:	Michael Gnant, MD	Austrian Breast & Colorectal Cancer Study Group
Study Director:	Guenther Steger, MD	Austrian Breast & Colorectal Cancer Study Group

More Information

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Responsible Party:	Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:	NCT01015625 History of Changes
Other Study ID Numbers:	ABCSG 28 / POSYTIVE, ABCSG 28
Study First Received:	November 17, 2009
Last Updated:	February 28, 2013
Health Authority:	Austria: Agency for Health and Food Safety

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:

breast cancer
ABCSG
POSYTIVE
growth factor
median survival
surgery on demand
surgical therapy

blood specimen
tissue specimen
VEGF
TGF
circulating tumor cells
stem cells

Additional relevant MeSH terms:

Breast Neoplasms
Neoplastic Cells, Circulating
Neoplasm Metastasis
Neoplasms by Site
Neoplasms

Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013

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