Role of Surgery for the Primary in Patients With Breast Cancer Stage IV.
NCT ID: NCT01906112
Last Updated: 2015-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2013-08-31
2019-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Controlled
No surgery for primary breast tumor.
No interventions assigned to this group
Study
Surgery for primary breast tumor.
Surgery for primary breast tumor.
Complete resection of primary breast tumor(Lumpectomy or mastectomy)
Interventions
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Surgery for primary breast tumor.
Complete resection of primary breast tumor(Lumpectomy or mastectomy)
Eligibility Criteria
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Inclusion Criteria
* 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 unresectable primary breast tumor or extensive chest wall disease.
ALL
Yes
Sponsors
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Vichaiyut Hospital
OTHER
National Cancer Institute, Thailand
OTHER_GOV
Responsible Party
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AKANIST PIYAPANT, MD.,FRCST.
Surgical Oncologist.
Principal Investigators
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AKANIST PIYAPANT, MD.,FRCST.
Role: PRINCIPAL_INVESTIGATOR
Phyathai2 Hospital , Bangkok, Thailand
Locations
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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
National Cancer Institute
Ratchathewi, Bangkok, Thailand
Phramongkutklao Hospital
Ratchathewi, Bangkok, Thailand
Chonburi Cancer Hospital
Muang Chonburi, Changwat Chon Buri, Thailand
Khon Kaen University
Muang, Changwat Khon Kaen, Thailand
Suratthani Cancer Hospital
Muang Suratthani, Changwat Surat Thani, Thailand
Udon Thani Cancer Hospital
Muang Udon Thani, Changwat Udon Thani, Thailand
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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17_2013RC_IN305
Identifier Type: -
Identifier Source: org_study_id