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

February 26, 2015 updated by: AKANIST PIYAPANT, MD.,FRCST., National Cancer Institute, Thailand

Role of Surgery for the Primary in Patients With Breast Cancer Stage IV - A Prospective Randomized Multicenter Controlled Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Division Head & Neck and Breast, Department of Surgery. Faculty of Medicine Siriraj Hospital
      • Dusit, Bangkok, Thailand, 10300
        • Department of Surgery, Faculty of Medicine Vajira Hospital.
      • PhyaThai, Bangkok, Thailand, 10400
        • Phyathai 2 Hospital
      • Ratchathewi, Bangkok, Thailand, 10400
        • Phramongkutklao Hospital
      • Ratchathewi, Bangkok, Thailand, 10400
        • National Cancer Institute
    • Chonburi
      • Muang Chonburi, Chonburi, Thailand, 20000
        • Chonburi Cancer Hospital
    • Khon Kaen
      • Muang, Khon Kaen, Thailand, 40002
        • Khon Kaen University
    • Suratthani
      • Muang Suratthani, Suratthani, Thailand, 84100
        • Suratthani Cancer Hospital
    • Udon Thani
      • Muang Udon Thani, Udon Thani, Thailand, 41330
        • Udon Thani Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Controlled
No surgery for primary breast tumor.
Experimental: Study
Surgery for primary breast tumor.
Procedure: Surgery for primary breast tumor.
Complete resection of primary breast tumor(Lumpectomy or mastectomy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Five years
Five years

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life & Uncontrolled chest wall disease
Time Frame: Five years
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Thailand

Collaborators

Vichaiyut Hospital

Investigators

  • Principal Investigator: AKANIST PIYAPANT, MD.,FRCST., Phyathai2 Hospital , Bangkok, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

July 15, 2013

First Submitted That Met QC Criteria

July 19, 2013

First Posted (Estimate)

July 23, 2013

Study Record Updates

Last Update Posted (Estimate)

February 27, 2015

Last Update Submitted That Met QC Criteria

February 26, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17_2013RC_IN305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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