Carcinoma Breast Stage IVPhase 3NCT01906112
Role of Surgery for the Primary in Patients With Breast Cancer Stage IV.
A Phase 3 study testing Surgery for primary breast tumor. in people with Carcinoma Breast Stage IV, run by National Cancer Institute, Thailand at 9 sites in Thailand.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Carcinoma Breast Stage IV
- What is being tested?
- Surgery for primary breast tumor.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 9 sitesThailand
- Study dates
- Aug 2013to Aug 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Thailand9 sites
Division Head & Neck and Breast, Department of Surgery. Faculty of Medicine Siriraj Hospital
Bangkok Noi, Bangkok, 10700
Department of Surgery, Faculty of Medicine Vajira Hospital.
Dusit, Bangkok, 10300
Khon Kaen University
Muang, Changwat Khon Kaen, 40002
Chonburi Cancer Hospital
Muang Chonburi, Changwat Chon Buri, 20000
Suratthani Cancer Hospital
Muang Suratthani, Changwat Surat Thani, 84100
Udon Thani Cancer Hospital
Muang Udon Thani, Changwat Udon Thani, 41330
Phyathai 2 Hospital
PhyaThai, Bangkok, 10400
National Cancer Institute
Ratchathewi, Bangkok, 10400
Phramongkutklao Hospital
Ratchathewi, Bangkok, 10400
About this study
Official title: 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.
- Conditions
- Carcinoma Breast Stage IV
- Being tested
- Surgery for primary breast tumor.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for primary breast tumor.Procedure or surgery
Complete resection of primary breast tumor(Lumpectomy or mastectomy)
| Study group | Role | What they receive |
|---|---|---|
| Controlled | No intervention | No surgery for primary breast tumor. |
| Study | Experimental | Surgery for primary breast tumor. Receives: Procedure: Surgery for primary breast tumor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Five years
Secondary outcomes (1)
Quality of life & Uncontrolled chest wall disease
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014 (estimated)
- Study completionAug 2019 (estimated)
Why it stopped: Low accrual and no further funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Carcinoma Breast Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Thailand
- Sponsor type
- Other government
- Collaborators
- Vichaiyut Hospital
- Responsible party
- Principal investigator, AKANIST PIYAPANT, MD.,FRCST., National Cancer Institute, Thailand
- Investigators
- AKANIST PIYAPANT, MD.,FRCST., Principal investigator, Phyathai2 Hospital , Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906112
- Sponsor's protocol ID
- 17_2013RC_IN305
- Status last verified
- Feb 2015
- First submitted
- 15 Jul 2013
- Last updated
- 27 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 12407345Gnerlich 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.
PubMed 17522944Rapiti 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.
PubMed 16702580Shien 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.
PubMed 19212646Neuman 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.
PubMed 20101736Nguyen 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.
PubMed 22330986
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Surgery for the Primary in Patients With Breast Cancer Stage IV - A Prospective Randomized Multicenter Controlled Trial
- ClinicalTrials.gov ID
- NCT01906112
- Acronym / sponsor ID
- 17_2013RC_IN305
- Conditions
- Carcinoma Breast Stage IV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low accrual and no further funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute, ThailandOther government
- Collaborators
- Vichaiyut Hospital
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlled | No intervention | –No surgery for primary breast tumor. |
| Study | Experimental | Procedure: Surgery for primary breast tumor.Surgery for primary breast tumor. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery for primary breast tumor.Complete resection of primary breast tumor(Lumpectomy or mastectomy) | Procedure or surgery | Study |
Primary outcome
Overall survival
Time frame: Five years
1 secondary outcome
Quality of life & Uncontrolled chest wall disease
Time frame: Five years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
- Background: PubMed 12407345Khan 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.
- Background: PubMed 17522944Gnerlich 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.
- Background: PubMed 16702580Rapiti 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.
- Background: PubMed 19212646Shien 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.
- Background: PubMed 20101736Neuman 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.
- Background: PubMed 22330986Nguyen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AKANIST PIYAPANT, MD.,FRCST. principal investigator
Phyathai2 Hospital , Bangkok, Thailand
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surgery for primary breast tumor. in people with Carcinoma Breast Stage IV, run by National Cancer Institute, Thailand at 9 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01906112, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2015.