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

Carcinoma Breast Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01906112
• Other study ID #: 17_2013RC_IN305
• Status: Withdrawn
• Phase: Phase 3
• First received: July 15, 2013
• Last updated: February 26, 2015
• Start date: August 2013
• Est. completion date: August 2019

Study information

• Verified date: February 2015
• Source: National Cancer Institute, Thailand
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2019
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma Breast Stage IV

Intervention

Procedure:
• Surgery for primary breast tumor.
Complete resection of primary breast tumor(Lumpectomy or mastectomy)

Locations

Country	Name	City	State
Thailand	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	Khon Kaen University	Muang	Khon Kaen
Thailand	Chonburi Cancer Hospital	Muang Chonburi	Chonburi
Thailand	Suratthani Cancer Hospital	Muang Suratthani	Suratthani
Thailand	Udon Thani Cancer Hospital	Muang Udon Thani	Udon Thani
Thailand	Phyathai 2 Hospital	PhyaThai	Bangkok
Thailand	National Cancer Institute	Ratchathewi	Bangkok
Thailand	Phramongkutklao Hospital	Ratchathewi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Institute, Thailand	Vichaiyut Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (6)

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. Epub 2007 May 24. — View 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. — View 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. — View Citation

Nguyen DA, Truong PT, Lesperance ML et al. Can locoregional treatment of the primary tumor improve outcomes for women with stage IV breast cancer at diagnosis? Proceedings of 53rd Annual Meeting of the American Society for Radiation Oncology. Int. J. Radiat. Oncol. Biol. Phys. (2011)

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. Epub 2006 May 15. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		Five years	No
Secondary	Quality of life & Uncontrolled chest wall disease		Five years	No