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

Primary Purpose

Carcinoma Breast Stage IV

Status
Withdrawn
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Surgery for primary breast tumor.
Sponsored by
National Cancer Institute, Thailand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma Breast Stage IV

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Division Head & Neck and Breast, Department of Surgery. Faculty of Medicine Siriraj Hospital
  • Department of Surgery, Faculty of Medicine Vajira Hospital.
  • Phyathai 2 Hospital
  • National Cancer Institute
  • Phramongkutklao Hospital
  • Chonburi Cancer Hospital
  • Khon Kaen University
  • Suratthani Cancer Hospital
  • Udon Thani Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Controlled

Study

Arm Description

No surgery for primary breast tumor.

Surgery for primary breast tumor.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Quality of life & Uncontrolled chest wall disease

Full Information

First Posted
July 15, 2013
Last Updated
February 26, 2015
Sponsor
National Cancer Institute, Thailand
Collaborators
Vichaiyut Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01906112
Brief Title
Role of Surgery for the Primary in Patients With Breast Cancer Stage IV.
Official Title
Role of Surgery for the Primary in Patients With Breast Cancer Stage IV - A Prospective Randomized Multicenter Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Low accrual and no further funding.
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Thailand
Collaborators
Vichaiyut Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma Breast Stage IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Controlled
Arm Type
No Intervention
Arm Description
No surgery for primary breast tumor.
Arm Title
Study
Arm Type
Experimental
Arm Description
Surgery for primary breast tumor.
Intervention Type
Procedure
Intervention Name(s)
Surgery for primary breast tumor.
Intervention Description
Complete resection of primary breast tumor(Lumpectomy or mastectomy)
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
Five years
Secondary Outcome Measure Information:
Title
Quality of life & Uncontrolled chest wall disease
Time Frame
Five years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AKANIST PIYAPANT, MD.,FRCST.
Organizational Affiliation
Phyathai2 Hospital , Bangkok, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division Head & Neck and Breast, Department of Surgery. Faculty of Medicine Siriraj Hospital
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Department of Surgery, Faculty of Medicine Vajira Hospital.
City
Dusit
State/Province
Bangkok
ZIP/Postal Code
10300
Country
Thailand
Facility Name
Phyathai 2 Hospital
City
PhyaThai
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
National Cancer Institute
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Phramongkutklao Hospital
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Chonburi Cancer Hospital
City
Muang Chonburi
State/Province
Chonburi
ZIP/Postal Code
20000
Country
Thailand
Facility Name
Khon Kaen University
City
Muang
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Suratthani Cancer Hospital
City
Muang Suratthani
State/Province
Suratthani
ZIP/Postal Code
84100
Country
Thailand
Facility Name
Udon Thani Cancer Hospital
City
Muang Udon Thani
State/Province
Udon Thani
ZIP/Postal Code
41330
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
12407345
Citation
Khan SA, Stewart AK, Morrow M. Does aggressive local therapy improve survival in metastatic breast cancer? Surgery. 2002 Oct;132(4):620-6; discussion 626-7. doi: 10.1067/msy.2002.127544.
Results Reference
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PubMed Identifier
17522944
Citation
Gnerlich J, Jeffe DB, Deshpande AD, Beers C, Zander C, Margenthaler JA. Surgical removal of the primary tumor increases overall survival in patients with metastatic breast cancer: analysis of the 1988-2003 SEER data. Ann Surg Oncol. 2007 Aug;14(8):2187-94. doi: 10.1245/s10434-007-9438-0. Epub 2007 May 24.
Results Reference
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PubMed Identifier
16702580
Citation
Rapiti E, Verkooijen HM, Vlastos G, Fioretta G, Neyroud-Caspar I, Sappino AP, Chappuis PO, Bouchardy C. Complete excision of primary breast tumor improves survival of patients with metastatic breast cancer at diagnosis. J Clin Oncol. 2006 Jun 20;24(18):2743-9. doi: 10.1200/JCO.2005.04.2226. Epub 2006 May 15.
Results Reference
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PubMed Identifier
19212646
Citation
Shien T, Kinoshita T, Shimizu C, Hojo T, Taira N, Doihara H, Akashi-Tanaka S. Primary tumor resection improves the survival of younger patients with metastatic breast cancer. Oncol Rep. 2009 Mar;21(3):827-32.
Results Reference
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PubMed Identifier
20101736
Citation
Neuman HB, Morrogh M, Gonen M, Van Zee KJ, Morrow M, King TA. Stage IV breast cancer in the era of targeted therapy: does surgery of the primary tumor matter? Cancer. 2010 Mar 1;116(5):1226-33. doi: 10.1002/cncr.24873.
Results Reference
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PubMed Identifier
22330986
Citation
Nguyen DH, Truong PT, Alexander C, Walter CV, Hayashi E, Christie J, Lesperance M. Can locoregional treatment of the primary tumor improve outcomes for women with stage IV breast cancer at diagnosis? Int J Radiat Oncol Biol Phys. 2012 Sep 1;84(1):39-45. doi: 10.1016/j.ijrobp.2011.11.046. Epub 2012 Feb 11.
Results Reference
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Role of Surgery for the Primary in Patients With Breast Cancer Stage IV.

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