NCT01906112

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2013

Longer than P75 for phase_3

Geographic Reach
1 country

9 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

February 27, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

July 15, 2013

Last Update Submit

February 26, 2015

Conditions

Carcinoma Breast Stage IV

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Five years

Secondary Outcomes (1)

  • Quality of life & Uncontrolled chest wall disease

    Five years

Study Arms (2)

Controlled

NO INTERVENTION

No surgery for primary breast tumor.

Study

EXPERIMENTAL

Surgery for primary breast tumor.

Procedure: Surgery for primary breast tumor.

Interventions

Surgery for primary breast tumor.PROCEDURE

Complete resection of primary breast tumor(Lumpectomy or mastectomy)

Study

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Division Head & Neck and Breast, Department of Surgery. Faculty of Medicine Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Department of Surgery, Faculty of Medicine Vajira Hospital.

Dusit, Bangkok, 10300, Thailand

Location

Phyathai 2 Hospital

PhyaThai, Bangkok, 10400, Thailand

Location

National Cancer Institute

Ratchathewi, Bangkok, 10400, Thailand

Location

Phramongkutklao Hospital

Ratchathewi, Bangkok, 10400, Thailand

Location

Chonburi Cancer Hospital

Muang Chonburi, Changwat Chon Buri, 20000, Thailand

Location

Khon Kaen University

Muang, Changwat Khon Kaen, 40002, Thailand

Location

Suratthani Cancer Hospital

Muang Suratthani, Changwat Surat Thani, 84100, Thailand

Location

Udon Thani Cancer Hospital

Muang Udon Thani, Changwat Udon Thani, 41330, Thailand

Location

Related Publications (6)

  • 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.

    PMID: 12407345BACKGROUND

  • 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.

    PMID: 17522944BACKGROUND

  • 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.

    PMID: 16702580BACKGROUND

  • 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.

    PMID: 19212646BACKGROUND

  • 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.

    PMID: 20101736BACKGROUND

  • 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.

    PMID: 22330986BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • AKANIST PIYAPANT, MD.,FRCST.

    Phyathai2 Hospital , Bangkok, Thailand

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgical Oncologist.

Study Record Dates

First Submitted

July 15, 2013

First Posted

July 23, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2019

Last Updated

February 27, 2015

Record last verified: 2015-02

Locations

TH(9)