Breast CancerNCT00557986
Local Surgery for Metastatic Breast Cancer
A study testing Primary surgery in people with Breast Cancer, run by Federation of Breast Diseases Societies at 7 sites in Turkey (Türkiye).
Trial summary
Primary treatments for metastatic breast cancer are chemotherapy and radiation therapy, and surgery is reserved for tumor related complications such as bleeding. Retrospective studies showed that surgical removal of the primary tumor improves survival of patients with metastatic breast cancer at diagnosis. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Primary surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 7 sitesTurkey (Türkiye)
- Study dates
- Nov 2007to Nov 2012
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women with metastatic breast cancer at the initial diagnosis
Who cannot join
- Women needs breast surgery at the time of initial diagnosis (such as bleeding, necrosis, etc)
- who have systemic morbidity that do not allows her to be in the trial,
- who have synchronous breast cancer at the contralateral breast,
- who have a previous cancer history or another primary cancer history and metastasis at the past,
- who have palpable lymph node/nodes at the contralateral axilla,
- who do not agree to participate the trial
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Turkey (Türkiye)7 sites
Cukurova University
Adana
Ankara Onkoloji Hastanesi
Ankara
Adnan Menderes University
Aydin, 09100
Izzet Baysal University
Bolu
Istanbul University Medical faculty
Istanbul
Marmara Univesity School of Medicine
Istanbul
Cumhuriyet University Medical School
Sivas
About this study
Official title: The Effect of Primary Surgical Treatment on Survival in Patients With Metastatic Breast Cancer at Diagnosis
Primary treatments for metastatic breast cancer are chemotherapy and radiation therapy, and surgery is reserved for tumor related complications such as bleeding. Retrospective studies showed that surgical removal of the primary tumor improves survival of patients with metastatic breast cancer at diagnosis. We hypothesis and testing that surgical removal of the primary tumor will lead to an improvement of overall survival
Read the detailed description
This is a randomised, controled clinical trial. Our aim is to observe whether primary surgery improves survival in metastatic breast cancer. Women who have metastatic breast cancer at the initial diagnosis will be included in the study. There will be two study arms: primary surgery and systemic chemotherapy groups.
In the primary surgery group patients will have adjuvant therapies after they had the proper surgery. In the systemic chemotherapy group patients will be followed after their initial therapy and will have surgery only if they have locoregional problems (such as wide necrosis or bleeding, etc). During the follow-up period, patients will be seen in every 6 months.
- Conditions
- Breast Cancer
- Being tested
- Primary surgery
- Keywords
- 1-Metastatic breast cancer, 2-Surgery, 3-Survival
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary surgeryProcedure or surgery
Primary breast surgery before systemic therapy
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | Standard Systemic Therapy only group (no primary surgery) |
| B | Other | Surgery group Receives: Procedure: Primary surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: all cause mortality
Measured: 5 years
Secondary outcomes (2)
Quality of life
Measured: 5 year
mordities
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2012
- Study completionNov 2012
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 Breast CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federation of Breast Diseases Societies
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University, Abant Izzet Baysal University, Marmara University
- Responsible party
- Sponsor
- Investigators
- Atilla Soran, MD, MPH, Study chair, University of PittsburghAtilla Soran, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557986
- Sponsor's protocol ID
- MF07-01
- Status last verified
- Aug 2016
- First submitted
- 13 Nov 2007
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16702580Babiera GV, Rao R, Feng L, Meric-Bernstam F, Kuerer HM, Singletary SE, Hunt KK, Ross MI, Gwyn KM, Feig BW, Ames FC, Hortobagyi GN. Effect of primary tumor extirpation in breast cancer patients who present with stage IV disease and an intact primary tumor. Ann Surg Oncol. 2006 Jun;13(6):776-82. doi: 10.1245/ASO.2006.03.033. Epub 2006 Apr 17.
PubMed 16614878Soran A, Ozmen V, Ozbas S, Karanlik H, Muslumanoglu M, Igci A, Canturk NZ, Utkan Z, Evrensel T, Sezgin E; MF07-01 Study Group. Primary Surgery with Systemic Therapy in Patients with de Novo Stage IV Breast Cancer: 10-year Follow-up; Protocol MF07-01 Randomized Clinical Trial. J Am Coll Surg. 2021 Dec;233(6):742-751.e5. doi: 10.1016/j.jamcollsurg.2021.08.686. Epub 2021 Sep 13.
PubMed 34530124Soran A, Soyder A, Ozbas S, Ozmen V, Karanlik H, Igci A, Muslumanoglu M, Evrensel T, Canturk Z, Utkan Z, Ozaslan C, Uras C, Ugurlu U, Col C, Cabioglu N, Uzunkoy A, Gulluoglu BM, Erdem E, Konca C, Sezgin E; Breast Health Working Group International (supported by the Turkish Federation of Breast Disease Societies). The role of loco-regional treatment in long-term quality of life in de novo stage IV breast cancer patients: protocol MF07-01Q. Support Care Cancer. 2021 Jul;29(7):3823-3830. doi: 10.1007/s00520-020-05905-z. Epub 2020 Nov 26.
PubMed 33242163Soran A, Ozmen V, Ozbas S, Karanlik H, Muslumanoglu M, Igci A, Canturk Z, Utkan Z, Ozaslan C, Evrensel T, Uras C, Aksaz E, Soyder A, Ugurlu U, Col C, Cabioglu N, Bozkurt B, Uzunkoy A, Koksal N, Gulluoglu BM, Unal B, Atalay C, Yildirim E, Erdem E, Salimoglu S, Sezer A, Koyuncu A, Gurleyik G, Alagol H, Ulufi N, Berberoglu U, Dulger M, Cengiz O, Sezgin E, Johnson R. Randomized Trial Comparing Resection of Primary Tumor with No Surgery in Stage IV Breast Cancer at Presentation: Protocol MF07-01. Ann Surg Oncol. 2018 Oct;25(11):3141-3149. doi: 10.1245/s10434-018-6494-6. Epub 2018 May 17.
PubMed 29777404Soran A, Ozbas S, Kelsey SF, Gulluoglu BM. Randomized trial comparing locoregional resection of primary tumor with no surgery in stage IV breast cancer at the presentation (Protocol MF07-01): a study of Turkish Federation of the National Societies for Breast Diseases. Breast J. 2009 Jul-Aug;15(4):399-403. doi: 10.1111/j.1524-4741.2009.00744.x. Epub 2009 May 22.
PubMed 19496782
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Primary Surgical Treatment on Survival in Patients With Metastatic Breast Cancer at Diagnosis
- ClinicalTrials.gov ID
- NCT00557986
- Acronym / sponsor ID
- MF07-01
- Conditions
- Breast Cancer
- Keywords
- 1-Metastatic breast cancer, 2-Surgery, 3-Survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Federation of Breast Diseases SocietiesUniversity, hospital or other
- Collaborators
- Istanbul University, Abant Izzet Baysal University, Marmara University
- Study start
- Nov 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 14 Nov 2007 (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.
Primary treatments for metastatic breast cancer are chemotherapy and radiation therapy, and surgery is reserved for tumor related complications such as bleeding. Retrospective studies showed that surgical removal of the primary tumor improves survival of patients with metastatic breast cancer at diagnosis. We hypothesis and testing that surgical removal of the primary tumor will lead to an improvement of overall survival
Detailed description
This is a randomised, controled clinical trial. Our aim is to observe whether primary surgery improves survival in metastatic breast cancer. Women who have metastatic breast cancer at the initial diagnosis will be included in the study. There will be two study arms: primary surgery and systemic chemotherapy groups.
In the primary surgery group patients will have adjuvant therapies after they had the proper surgery. In the systemic chemotherapy group patients will be followed after their initial therapy and will have surgery only if they have locoregional problems (such as wide necrosis or bleeding, etc). During the follow-up period, patients will be seen in every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –Standard Systemic Therapy only group (no primary surgery) |
| B | Other | Procedure: Primary surgerySurgery group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women with metastatic breast cancer at the initial diagnosis
Key exclusion criteria (6 listed)
- Women needs breast surgery at the time of initial diagnosis (such as bleeding, necrosis, etc)
- who have systemic morbidity that do not allows her to be in the trial,
- who have synchronous breast cancer at the contralateral breast,
- who have a previous cancer history or another primary cancer history and metastasis at the past,
- who have palpable lymph node/nodes at the contralateral axilla,
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 |
|---|---|---|
| Primary surgeryPrimary breast surgery before systemic therapy | Procedure or surgery | B |
Primary outcome
Measure: all cause mortality
Time frame: 5 years
2 secondary outcomes
Quality of life
Time frame: 5 year
mordities
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- 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 16614878Babiera GV, Rao R, Feng L, Meric-Bernstam F, Kuerer HM, Singletary SE, Hunt KK, Ross MI, Gwyn KM, Feig BW, Ames FC, Hortobagyi GN. Effect of primary tumor extirpation in breast cancer patients who present with stage IV disease and an intact primary tumor. Ann Surg Oncol. 2006 Jun;13(6):776-82. doi: 10.1245/ASO.2006.03.033. Epub 2006 Apr 17.
- Derived from this study: PubMed 34530124Soran A, Ozmen V, Ozbas S, Karanlik H, Muslumanoglu M, Igci A, Canturk NZ, Utkan Z, Evrensel T, Sezgin E; MF07-01 Study Group. Primary Surgery with Systemic Therapy in Patients with de Novo Stage IV Breast Cancer: 10-year Follow-up; Protocol MF07-01 Randomized Clinical Trial. J Am Coll Surg. 2021 Dec;233(6):742-751.e5. doi: 10.1016/j.jamcollsurg.2021.08.686. Epub 2021 Sep 13.
- Derived from this study: PubMed 33242163Soran A, Soyder A, Ozbas S, Ozmen V, Karanlik H, Igci A, Muslumanoglu M, Evrensel T, Canturk Z, Utkan Z, Ozaslan C, Uras C, Ugurlu U, Col C, Cabioglu N, Uzunkoy A, Gulluoglu BM, Erdem E, Konca C, Sezgin E; Breast Health Working Group International (supported by the Turkish Federation of Breast Disease Societies). The role of loco-regional treatment in long-term quality of life in de novo stage IV breast cancer patients: protocol MF07-01Q. Support Care Cancer. 2021 Jul;29(7):3823-3830. doi: 10.1007/s00520-020-05905-z. Epub 2020 Nov 26.
- Derived from this study: PubMed 29777404Soran A, Ozmen V, Ozbas S, Karanlik H, Muslumanoglu M, Igci A, Canturk Z, Utkan Z, Ozaslan C, Evrensel T, Uras C, Aksaz E, Soyder A, Ugurlu U, Col C, Cabioglu N, Bozkurt B, Uzunkoy A, Koksal N, Gulluoglu BM, Unal B, Atalay C, Yildirim E, Erdem E, Salimoglu S, Sezer A, Koyuncu A, Gurleyik G, Alagol H, Ulufi N, Berberoglu U, Dulger M, Cengiz O, Sezgin E, Johnson R. Randomized Trial Comparing Resection of Primary Tumor with No Surgery in Stage IV Breast Cancer at Presentation: Protocol MF07-01. Ann Surg Oncol. 2018 Oct;25(11):3141-3149. doi: 10.1245/s10434-018-6494-6. Epub 2018 May 17.
- Derived from this study: PubMed 19496782Soran A, Ozbas S, Kelsey SF, Gulluoglu BM. Randomized trial comparing locoregional resection of primary tumor with no surgery in stage IV breast cancer at the presentation (Protocol MF07-01): a study of Turkish Federation of the National Societies for Breast Diseases. Breast J. 2009 Jul-Aug;15(4):399-403. doi: 10.1111/j.1524-4741.2009.00744.x. Epub 2009 May 22.
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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.
Atilla Soran, MD, MPH study chair
University of Pittsburgh
Atilla Soran, MD, MPH principal investigator
University of Pittsburgh
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary surgery in people with Breast Cancer, run by Federation of Breast Diseases Societies at 7 sites in Turkey (Türkiye).
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure: all cause mortality (time frame: 5 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 NCT00557986, 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 12 Aug 2016.