Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer (POSYTIVE)

This study is ongoing, but not recruiting participants.
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: November 17, 2015
Last verified: November 2015
  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:


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: October 2010
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2021 (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

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Austria
Hospital Guessing
Guessing, Burgenland, Austria, 7540
Hospital Oberpullendorf
Oberpullendorf, Burgenland, Austria, 7350
Ordination Dr. Wette
St. Veit a. d. Glan, Carinthia, Austria, 9300
Gynaegological Medical University Graz
Graz, Styria, Austria, 8036
Medical University Graz, Oncology
Graz, Styria, Austria, 8036
Medical University of Innsbruck
Innsbruck, Tyrol, Austria, 6020
Hospital BHS Linz, Coop. Study Group
Linz, Upper Austria, Austria, 4010
Hospital Elisabethinen Linz
Linz, Upper Austria, Austria, 4010
General Hospital Linz
Linz, Upper Austria, Austria, 4020
Klinikum Wels-Grieskirchen GmbH
Wels, Upper Austria, Austria, 4600
State Hospital Feldkirch
Feldkirch, Vorarlberg, Austria, 6807
Paracelsus Medical University Salzburg-Oncology, Coop. Group
Salzburg, Austria, 5020
Medical University of Vienna-General Hospital Vienna
Vienna, Austria, 1090
Medical University of Vienna
Vienna, Austria, 1090
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

Publications:
Blanchard DK, Bhatia P, Hilsenbeck SG, Elledge RM. Does surgical management of stage IV breast cancer effect outcome? SABCC 2006, San Antonio

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: November 17, 2015
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 July 28, 2016