Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer

Circulating Tumor Cells Clinical Trial

— POSYTIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01015625
• Other study ID #: ABCSG 28 / POSYTIVE
• Secondary ID: ABCSG 28
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: July 2022

Study information

• Verified date: June 2023
• Source: Austrian Breast & Colorectal Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Circulating Tumor Cells
• Neoplasm Metastasis
• Neoplastic Cells, Circulating
• Synchronous Metastasized Breast Cancer

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Austria	State Hospital Feldkirch	Feldkirch	Vorarlberg
Austria	Gynaegological Medical University Graz	Graz	Styria
Austria	Medical University Graz, Oncology	Graz	Styria
Austria	Hospital Guessing	Guessing	Burgenland
Austria	Medical University of Innsbruck	Innsbruck	Tyrol
Austria	General Hospital Linz	Linz	Upper Austria
Austria	Ordensklinikum Linz GmbH - BHS Linz, Coop. Study Group	Linz	Upper Austria
Austria	Ordensklinikum Linz GmbH - Elisabethinen Linz	Linz	Upper Austria
Austria	Hospital Oberpullendorf	Oberpullendorf	Burgenland
Austria	Paracelsus Medical University Salzburg-Oncology, Coop. Group	Salzburg
Austria	Ordination Dr. Wette	St. Veit a. d. Glan	Carinthia
Austria	Medical University of Vienna	Vienna
Austria	Medical University of Vienna-General Hospital Vienna	Vienna
Austria	Klinikum Wels-Grieskirchen GmbH	Wels	Upper Austria

Sponsors (10)

Lead Sponsor	Collaborator
Austrian Breast & Colorectal Cancer Study Group	Amgen, AstraZeneca, Bayer, Fond of the Viennese Mayor, GlaxoSmithKline, Hoffmann-La Roche, Merck Sharp & Dohme LLC, Sanofi Aventis GmbH, Austria, Wyeth Lederle Pharma GmbH, Austria

Country where clinical trial is conducted

Austria, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 point at which 50% of all randomized patient died
Secondary	time to distant progression (TTPd)		Time to treatment change due to systemic progression
Secondary	time to local progression (TTPl)		Increase in size >25% of the primary tumor in arm B (no local therapy). Local recurrence in arm A (local therapy).