Clinical trial NCT01906112: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Carcinoma Breast Stage IV
Lead sponsor: National Cancer Institute, Thailand
Sponsor class: OTHER_GOV
Collaborators: name: Vichaiyut Hospital
First posted: 2013-07-23
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall survival
timeFrame: Five years
Secondary outcomes:
measure: Quality of life & Uncontrolled chest wall disease
timeFrame: Five years
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Division Head & Neck and Breast, Department of Surgery. Faculty of Medicine Siriraj Hospital
state: Bangkok
city: Dusit
country: Thailand
facility: Department of Surgery, Faculty of Medicine Vajira Hospital.
state: Bangkok
city: PhyaThai
country: Thailand
facility: Phyathai 2 Hospital
state: Bangkok
city: Ratchathewi
country: Thailand
facility: National Cancer Institute
state: Bangkok
city: Ratchathewi
country: Thailand
facility: Phramongkutklao Hospital
state: Bangkok
city: Muang Chonburi
country: Thailand
facility: Chonburi Cancer Hospital
state: Chonburi
city: Muang
country: Thailand
facility: Khon Kaen University
state: Khon Kaen
city: Muang Suratthani
country: Thailand
facility: Suratthani Cancer Hospital
state: Suratthani
city: Muang Udon Thani
country: Thailand
facility: Udon Thani Cancer Hospital
state: Udon Thani
Study officials:
affiliation: Phyathai2 Hospital , Bangkok, Thailand
name: AKANIST PIYAPANT, MD.,FRCST.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.