Breast CancerBREAST-MRINCT02798796
Brazilian Randomized Study - Impact of MRI for Breast Cancer
A study testing MRI in people with Breast Cancer, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the ability of MRI to select patients for conservative treatment of breast cancer. Participants: female, over 18 years with breast cancer, stages I, II and III candidates for conservative surgery will be randomly randomized to do MRI or not according mammary density. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2014to May 2025
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female,
- Over 18 years with breast cancer
- breast cancer stage 0 to III according to AJCC 7th Edition guideline
Who cannot join
- Contra-indication for breast MRI (ex. Metal implant)
- Claustrophobia
- Impossibility to stay in the prone position for more than an hour
- History of allergic reaction to the paramagnetic contrast
- History of chronic kidney disease on dialysis
- Personal history of breast cancer treated surgically in the last 12 months.
- Pregnancy or breastfeeding past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brazilian Randomized Study - Impact of Preoperative Magnetic Resonance in the Evaluation for Breast Cancer Conservative Surgery
The aim of this study is to evaluate the ability of MRI to select patients for conservative treatment of breast cancer. Participants: female, over 18 years with breast cancer, stages I, II and III candidates for conservative surgery will be randomly randomized to do MRI or not according mammary density.
Read the detailed description
The aim of this study is to evaluate the ability of MRI to select patients for conservative treatment of breast cancer.An accurate assessment of the tumor is essential to select the best therapeutic strategy in the treatment of breast cancer.Currently, mammography, ultrasound and clinical examination are the standard techniques to assess the extent and location of the tumor.However, these imaging methods fail to assess the real size in approximately one third of patients eligible to conservative treatment.MRI has high sensitivity (95-100%) in the detection of invasive cancers as well as being able to detect hidden tumors, multifocality, multicentricity and cancer in the contralateral breast more often and greater accuracy than mammography or ultrasound.
- Conditions
- Breast Cancer
- Being tested
- MRI
- Keywords
- breast cancer, conservative surgery, MRI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
All patients will be submitted to MRI
| Study group | Role | What they receive |
|---|---|---|
| MRI Group | Experimental | MRI Group - all patients will be submitted to clinical examination, mammography and / or ultrasound, and breast MRI Receives: Device: MRI |
| Control Group | No intervention | Control group - all patients will be submitted to clinical examination, mammography and / or ultrasound of the breasts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
local relapse-free survival
presence of local and regional relapse during the follow up time
Measured: 5 years
Secondary outcomes (5)
overall survival between groups
Measured: 5 years
disease free-survival between groups
Measured: 5 years
Describe the percentage surgical change from conservative surgery to mastectomy
Measured: 6 months
MRI findings in modifying the surgical management
The proportion of patients whose surgical approach was modified to mastectomy
Measured: 6 months
reoperation rates
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startNov 2014
- Primary completionMay 2025
- Study completionMay 2025
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.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open label
- Masking
- None (open label)
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruna Salani Mota, Recruiting, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798796
- Sponsor's protocol ID
- 974.504
- Acronym
- BREAST-MRI
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2015
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brazilian Randomized Study - Impact of Preoperative Magnetic Resonance in the Evaluation for Breast Cancer Conservative Surgery
- ClinicalTrials.gov ID
- NCT02798796
- Acronym / sponsor ID
- BREAST-MRI / 974.504
- Conditions
- Breast Cancer
- Keywords
- breast cancer, conservative surgery, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- May 2025 (actual)
- Study completion
- May 2025 (actual)
- First posted
- 14 Jun 2016 (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 aim of this study is to evaluate the ability of MRI to select patients for conservative treatment of breast cancer. Participants: female, over 18 years with breast cancer, stages I, II and III candidates for conservative surgery will be randomly randomized to do MRI or not according mammary density.
Detailed description
The aim of this study is to evaluate the ability of MRI to select patients for conservative treatment of breast cancer.An accurate assessment of the tumor is essential to select the best therapeutic strategy in the treatment of breast cancer.Currently, mammography, ultrasound and clinical examination are the standard techniques to assess the extent and location of the tumor.However, these imaging methods fail to assess the real size in approximately one third of patients eligible to conservative treatment.MRI has high sensitivity (95-100%) in the detection of invasive cancers as well as being able to detect hidden tumors, multifocality, multicentricity and cancer in the contralateral breast more often and greater accuracy than mammography or ultrasound.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label
| Arm | Type | Receives |
|---|---|---|
| MRI Group | Experimental | Device: MRIMRI Group - all patients will be submitted to clinical examination, mammography and / or ultrasound, and breast MRI |
| Control Group | No intervention | –Control group - all patients will be submitted to clinical examination, mammography and / or ultrasound of the breasts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female,
- Over 18 years with breast cancer
- breast cancer stage 0 to III according to AJCC 7th Edition guideline
Key exclusion criteria (7 listed)
- Contra-indication for breast MRI (ex. Metal implant)
- Claustrophobia
- Impossibility to stay in the prone position for more than an hour
- History of allergic reaction to the paramagnetic contrast
- History of chronic kidney disease on dialysis
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 |
|---|---|---|
| MRIAll patients will be submitted to MRI | Device | MRI Group |
Primary outcome
local relapse-free survival
Time frame: 5 years
presence of local and regional relapse during the follow up time
5 secondary outcomes
overall survival between groups
Time frame: 5 years
disease free-survival between groups
Time frame: 5 years
Describe the percentage surgical change from conservative surgery to mastectomy
Time frame: 6 months
MRI findings in modifying the surgical management
Time frame: 6 months
reoperation rates
Time frame: 6 months
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 23 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Bruna Salani Mota, Recruiting principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Breast Cancer, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 7 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 23 Oct 2026. 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 Brazil. 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?
local relapse-free 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 23 Oct 2026.