Breast CancerNCT02125630
Bone Metastasis and Surgery in Breast Cancer
An observational study of Breast Cancer and Surgery, run by Federation of Breast Diseases Societies at 1 site in Turkey (Türkiye).
Trial summary
A registry trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may result in improved survival, but this… Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Surgery
- What is being tested?
- Surgery and Systemic therapy
- Type of treatment
- Surgery or procedure
- How many people
- 460 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Jun 2019
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All female patients diagnosed with de novo stage IV breast cancer
Who may be able to join
- Primary breast tumor amenable for complete surgical resection
- Patients in good physical condition for receiving protocol driven locoregional and systemic treatment
- Patients eligible for sentinel lymph node (SLN) biopsy and receiving radiotherapy.
Who cannot join
- Primary tumor not amenable for complete resection (such as tumor extending to neighboring tissues; T4a,c or inflammatory breast cancer; T4d)
- Primary tumor with extended infection, bleeding, or necrosis
- Patients with poor physical condition which prevents the patient from receiving protocol driven locoregional and systemic treatment
- Synchronous primary cancer at the contralateral breast
- Previous diagnosis of other cancers (excluding basal cell skin cancer
- Squamous cell skin cancer
Show all 10Show fewer
- Cervical intraepithelial neoplasia)
- Clinically involved contralateral axillary nodes
- Patients not suitable for adequate follow-up
- Failure to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Primary Surgery in Patients With Stage IV Breast Cancer With Bone Metastasis Only
A registry trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may result in improved survival, but this remains unproven. The early results of our ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women with distant metastases at presentation who receive loco-regional treatment for intact primary tumor compared with those who do not receive such treatment) showed that patients with bone metastasis only have a trend toward improved survival with initial surgery.
Read the detailed description
This registry trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may result in improved survival, but this remains unproven. The early results of our ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women with distant metastases at presentation who receive loco-regional treatment for intact primary tumor compared with those who do not receive such treatment) showed that patients with bone metastasis only have a trend toward improved survival with initial surgery. Our goal is to test if primary surgery improves overall survival in bone only metastasis.
- Conditions
- Breast Cancer, Surgery
- Being tested
- Surgery, Systemic therapy
- Keywords
- Metastatic breast carcer, Bone metastasis, surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Also called mastectomy, lumpectomy
Surgery to primary tumor
Systemic therapyDrug
Also called Chemotherapy, hormone therapy, biphosphanetes
Systemic therapy based on tumor phenotype
| Study group | Role | What they receive |
|---|---|---|
| Systemic therapy | Standart chemotherapy Receives: Drug: Systemic therapy | |
| Primary surgery | Standart surgery Receives: Procedure: Surgery | |
| Neoadjuvant chemotherapy | Standart chemotherapy followed by surgery Receives: Procedure: Surgery; Drug: Systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Years
Measured: 5 years
Secondary outcomes (1)
Locoregional progression
Number
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 posted29 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 460 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Federation of Breast Diseases Societies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Atilla Soran, MD, MPH, Study chair, University of PittsburghSerdar Ozbas, MD, Principal investigator, Guven HospitalLutfi Doğan, MD, Principal investigator, Ankara Onkoloji Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125630
- Sponsor's protocol ID
- BOMET MF14-01
- Other IDs
- PROTOCOL BOMET MF14-01
- Status last verified
- Jul 2019
- First submitted
- 27 Apr 2014
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Primary Surgery in Patients With Stage IV Breast Cancer With Bone Metastasis Only
- ClinicalTrials.gov ID
- NCT02125630
- Acronym / sponsor ID
- BOMET MF14-01
- Conditions
- Breast Cancer, Surgery
- Keywords
- Metastatic breast carcer, Bone metastasis, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Federation of Breast Diseases SocietiesUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 29 Apr 2014 (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.
A registry trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may result in improved survival, but this remains unproven. The early results of our ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women with distant metastases at presentation who receive loco-regional treatment for intact primary tumor compared with those who do not receive such treatment) showed that patients with bone metastasis only have a trend toward improved survival with initial surgery.
Detailed description
This registry trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may result in improved survival, but this remains unproven. The early results of our ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women with distant metastases at presentation who receive loco-regional treatment for intact primary tumor compared with those who do not receive such treatment) showed that patients with bone metastasis only have a trend toward improved survival with initial surgery. Our goal is to test if primary surgery improves overall survival in bone only metastasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Systemic therapy | – | Drug: Systemic therapyStandart chemotherapy |
| Primary surgery | – | Procedure: SurgeryStandart surgery |
| Neoadjuvant chemotherapy | – | Procedure: Surgery, Drug: Systemic therapyStandart chemotherapy followed by surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All female patients diagnosed with de novo stage IV breast cancer
Key inclusion criteria (3 listed)
- Primary breast tumor amenable for complete surgical resection
- Patients in good physical condition for receiving protocol driven locoregional and systemic treatment
- Patients eligible for sentinel lymph node (SLN) biopsy and receiving radiotherapy.
Key exclusion criteria (10 listed)
- Primary tumor not amenable for complete resection (such as tumor extending to neighboring tissues; T4a,c or inflammatory breast cancer; T4d)
- Primary tumor with extended infection, bleeding, or necrosis
- Patients with poor physical condition which prevents the patient from receiving protocol driven locoregional and systemic treatment
- Synchronous primary cancer at the contralateral breast
- Previous diagnosis of other cancers (excluding basal cell skin cancer
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 |
|---|---|---|
| SurgeryAlso: mastectomy, lumpectomySurgery to primary tumor | Procedure or surgery | Neoadjuvant chemotherapy, Primary surgery |
| Systemic therapyAlso: Chemotherapy, hormone therapy, biphosphanetesSystemic therapy based on tumor phenotype | Drug | Neoadjuvant chemotherapy, Systemic therapy |
Primary outcome
Overall survival
Time frame: 5 years
Years
1 secondary outcome
Locoregional progression
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 31 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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
Serdar Ozbas, MD principal investigator
Guven Hospital
Lutfi Doğan, MD principal investigator
Ankara Onkoloji Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Surgery, run by Federation of Breast Diseases Societies at 1 site 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 3 inclusion and 10 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2019.