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Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer (POSYTIVE)

Primary Purpose

Synchronous Metastasized Breast Cancer, Circulating Tumor Cells

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Surgery

Surgery on Demand

About this trial

This is an interventional prevention trial for Synchronous Metastasized Breast Cancer focused on measuring breast cancer, ABCSG, POSYTIVE, growth factor, median survival, surgery on demand, surgical therapy, blood specimen, tissue specimen, VEGF, TGF, circulating tumor cells, stem cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

A: Surgical Therapy

B: Surgery on Demand

Arm Description

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).

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.

Outcomes

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

Secondary Outcome Measures

time to distant progression (TTPd)

time to local progression (TTPl)

Full Information

NCT ID

NCT01015625

First Posted

November 17, 2009

Last Updated

June 13, 2023

Sponsor

Austrian Breast & Colorectal Cancer Study Group

Collaborators

Bayer, Amgen, Hoffmann-La Roche, AstraZeneca, Sanofi Aventis GmbH, Austria, Wyeth Lederle Pharma GmbH, Austria, GlaxoSmithKline, Merck Sharp & Dohme LLC, Fond of the Viennese Mayor

1. Study Identification

Unique Protocol Identification Number

NCT01015625

Brief Title

Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer

Acronym

POSYTIVE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

July 2022 (Actual)

Study Completion Date

July 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Austrian Breast & Colorectal Cancer Study Group

Collaborators

Bayer, Amgen, Hoffmann-La Roche, AstraZeneca, Sanofi Aventis GmbH, Austria, Wyeth Lederle Pharma GmbH, Austria, GlaxoSmithKline, Merck Sharp & Dohme LLC, Fond of the Viennese Mayor

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Synchronous Metastasized Breast Cancer, Circulating Tumor Cells

Keywords

breast cancer, ABCSG, POSYTIVE, growth factor, median survival, surgery on demand, surgical therapy, blood specimen, tissue specimen, VEGF, TGF, circulating tumor cells, stem cells

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A: Surgical Therapy

Arm Type

Other

Arm Description

Arm Title

B: Surgery on Demand

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Surgery

Intervention Description

lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II)

Intervention Type

Procedure

Intervention Name(s)

Surgery on Demand

Intervention Description

if necessary local therapy on demand

Primary Outcome Measure Information:

Title

Time Frame

time point at which 50% of all randomized patient died

Secondary Outcome Measure Information:

Title

time to distant progression (TTPd)

Time Frame

Time to treatment change due to systemic progression

Title

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).

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Florian Fitzal, MD

Organizational Affiliation

Austrian Breast & Colorectal Cancer Study Group

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Michael Gnant, MD

Organizational Affiliation

Austrian Breast & Colorectal Cancer Study Group

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Guenther Steger, MD

Organizational Affiliation

Austrian Breast & Colorectal Cancer Study Group

Official's Role

Study Director

Facility Information:

Facility Name

Hospital Guessing

City

Guessing

State/Province

Burgenland

ZIP/Postal Code

7540

Country

Austria

Facility Name

Hospital Oberpullendorf

City

Oberpullendorf

State/Province

Burgenland

ZIP/Postal Code

7350

Country

Austria

Facility Name

Ordination Dr. Wette

City

St. Veit a. d. Glan

State/Province

Carinthia

ZIP/Postal Code

9300

Country

Austria

Facility Name

Gynaegological Medical University Graz

City

Graz

State/Province

Styria

ZIP/Postal Code

8036

Country

Austria

Facility Name

Medical University Graz, Oncology

City

Graz

State/Province

Styria

ZIP/Postal Code

8036

Country

Austria

Facility Name

Medical University of Innsbruck

City

Innsbruck

State/Province

Tyrol

ZIP/Postal Code

6020

Country

Austria

Facility Name

Ordensklinikum Linz GmbH - BHS Linz, Coop. Study Group

City

Linz

State/Province

Upper Austria

ZIP/Postal Code

4010

Country

Austria

Facility Name

Ordensklinikum Linz GmbH - Elisabethinen Linz

City

Linz

State/Province

Upper Austria

ZIP/Postal Code

4010

Country

Austria

Facility Name

General Hospital Linz

City

Linz

State/Province

Upper Austria

ZIP/Postal Code

4020

Country

Austria

Facility Name

Klinikum Wels-Grieskirchen GmbH

City

Wels

State/Province

Upper Austria

ZIP/Postal Code

4600

Country

Austria

Facility Name

State Hospital Feldkirch

City

Feldkirch

State/Province

Vorarlberg

ZIP/Postal Code

6807

Country

Austria

Facility Name

Paracelsus Medical University Salzburg-Oncology, Coop. Group

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Medical University of Vienna-General Hospital Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Medical University of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Plan to Share IPD

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Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer

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Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer (POSYTIVE)

Synchronous Metastasized Breast Cancer, Circulating Tumor Cells

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial