Role of Surgery for the Primary in Patients With Breast Cancer Stage IV.

Phase 3

Withdrawn

• Conditions: Carcinoma Breast Stage IV
• Interventions: Procedure: Surgery for primary breast tumor.

• Registration Number: NCT01906112
• Lead Sponsor: National Cancer Institute, Thailand

Brief Summary

The purpose of this study is to determine benefits of surgery for the primary in patients with breast cancer stage IV in randomized controlled study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-07-19
• Study First Posted: 2013-07-23
• Study Start: 2013-08
• Primary Completion: 2014-08
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-26
• Last Update Posted: 2015-02-27
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Healthy breast cancer stage IV patients with resectable primary breast tumor.
• Resectable breast cancer stage IV patients who well response of visceral metastasis to systemic therapy and fit for surgery.

Exclusion Criteria

• Breast cancer stage IV patients with local complication of primary breast tumor that require surgery for palliation such as uncontrolled bleeding,large and non-healing ulcer or intractable pain.
• Breast cancer stage IV patients with unresectable primary breast tumor or extensive chest wall disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study	Surgery for primary breast tumor.	Surgery for primary breast tumor.

Primary Outcome Measures

Name	Time	Method
Overall survival	Five years

Secondary Outcome Measures

Name	Time	Method
Quality of life & Uncontrolled chest wall disease	Five years

Trial Locations

Locations (9)

National Cancer Institute; 🇹🇭 Ratchathewi, Bangkok, Thailand

Division Head & Neck and Breast, Department of Surgery. Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok Noi, Bangkok, Thailand

Department of Surgery, Faculty of Medicine Vajira Hospital.; 🇹🇭 Dusit, Bangkok, Thailand

Phyathai 2 Hospital; 🇹🇭 PhyaThai, Bangkok, Thailand

Khon Kaen University; 🇹🇭 Muang, Khon Kaen, Thailand

Udon Thani Cancer Hospital; 🇹🇭 Muang Udon Thani, Udon Thani, Thailand

Chonburi Cancer Hospital; 🇹🇭 Muang Chonburi, Chonburi, Thailand

Suratthani Cancer Hospital; 🇹🇭 Muang Suratthani, Suratthani, Thailand

Phramongkutklao Hospital; 🇹🇭 Ratchathewi, Bangkok, Thailand