- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01906112
Role of Surgery for the Primary in Patients With Breast Cancer Stage IV.
February 26, 2015 updated by: AKANIST PIYAPANT, MD.,FRCST., National Cancer Institute, Thailand
Role of Surgery for the Primary in Patients With Breast Cancer Stage IV - A Prospective Randomized Multicenter Controlled Trial
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bangkok
-
Bangkok Noi, Bangkok, Thailand, 10700
- Division Head & Neck and Breast, Department of Surgery. Faculty of Medicine Siriraj Hospital
-
Dusit, Bangkok, Thailand, 10300
- Department of Surgery, Faculty of Medicine Vajira Hospital.
-
PhyaThai, Bangkok, Thailand, 10400
- Phyathai 2 Hospital
-
Ratchathewi, Bangkok, Thailand, 10400
- Phramongkutklao Hospital
-
Ratchathewi, Bangkok, Thailand, 10400
- National Cancer Institute
-
-
Chonburi
-
Muang Chonburi, Chonburi, Thailand, 20000
- Chonburi Cancer Hospital
-
-
Khon Kaen
-
Muang, Khon Kaen, Thailand, 40002
- Khon Kaen University
-
-
Suratthani
-
Muang Suratthani, Suratthani, Thailand, 84100
- Suratthani Cancer Hospital
-
-
Udon Thani
-
Muang Udon Thani, Udon Thani, Thailand, 41330
- Udon Thani Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Controlled
No surgery for primary breast tumor.
|
|
Experimental: Study
Surgery for primary breast tumor.
|
Complete resection of primary breast tumor(Lumpectomy or mastectomy)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: Five years
|
Five years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life & Uncontrolled chest wall disease
Time Frame: Five years
|
Five years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: AKANIST PIYAPANT, MD.,FRCST., Phyathai2 Hospital , Bangkok, Thailand
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Anticipated)
August 1, 2014
Study Completion (Anticipated)
August 1, 2019
Study Registration Dates
First Submitted
July 15, 2013
First Submitted That Met QC Criteria
July 19, 2013
First Posted (Estimate)
July 23, 2013
Study Record Updates
Last Update Posted (Estimate)
February 27, 2015
Last Update Submitted That Met QC Criteria
February 26, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17_2013RC_IN305
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma Breast Stage IV
-
Thomas Jefferson UniversityWithdrawnAnatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | Recurrent Breast Carcinoma | Metastatic Breast Carcinoma | Refractory Breast CarcinomaUnited States
-
Roswell Park Cancer InstituteRecruitingAnatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | Metastatic Breast CarcinomaUnited States
-
M.D. Anderson Cancer CenterCompletedAnatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | Metastatic Breast CarcinomaUnited States
-
Roswell Park Cancer InstitutePfizerCompletedBreast Carcinoma | Anatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | Recurrent Breast Carcinoma | Metastatic Breast CarcinomaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingAnatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | Hormone Receptor Positive Breast Carcinoma | Metastatic Breast CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAnatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | Metastatic Breast CarcinomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)SuspendedAnatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | Metastatic Breast CarcinomaUnited States
-
Jules Bordet InstituteCompletedCarcinoma Breast Stage IVBelgium
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)Active, not recruitingAnatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | Hormone Receptor Positive Breast Carcinoma | Metastatic Breast CarcinomaUnited States, Puerto Rico, Ireland
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)WithdrawnAnatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | HER2 Positive Breast Carcinoma | Metastatic Breast CarcinomaUnited States
Clinical Trials on Surgery for primary breast tumor.
-
Hospital Universitari de BellvitgeRecruitingBiliary Stones | Midgut Carcinoid TumorSpain
-
Tata Memorial HospitalRecruitingBreast Cancer FemaleIndia
-
Jules Bordet InstituteCompletedInvasive Breast CancerBelgium
-
Danish Pain Research CenterDOLORisk Consortium; Aarhus University HospitalCompletedChronic Neuropathic Pain, Postoperative | Chronic Pain, Postoperative | Chronic Chemotherapy-induced Neuropathic Pain | Chronic Chemotherapy-induced Pain | Chronic Chemotherapy-induced Peripheral NeuropathyDenmark
-
Kevin MunroGöteborg University; University of Copenhagen; National Institute of Dental and... and other collaboratorsCompletedCleft PalateNorway, United Kingdom, Sweden, Brazil, Denmark
-
Centre Georges Francois LeclercRecruiting
-
Guizhou Medical UniversityUnknownRadiotherapy | Nonsmall Cell Lung Cancer, Stage IVChina
-
IRCCS SYNLAB SDNRecruiting
-
Tata Memorial HospitalCompletedCancer of the BreastIndia
-
Assistance Publique - Hôpitaux de ParisCompleted