Breast CancerPhase 3NCT00695916
MRI in Women With Newly Diagnosed Breast Cancer Prior to Breast Conserving Surgery
A Phase 3 study testing Breast MRI in people with Breast Cancer, run by Stanford University.
Trial summary
To see if performing breast MRI before a lumpectomy will help the surgeon successfully remove the entire cancer with normal tissue margins in a single operation thereby reducing the need for additional surgical procedures. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast MRI
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DCIS less than 5 cm. T1/T2 invasive breast cancer. Patient is a suitable candidate for breast conservation and wishes this as the primary clinical approach
- No breast MRI within the past year. Prior core biopsy, but no prior excision allowed. Patient has completed conventional imaging workup with mammography ultrasound as indicated and there is no clinical indication for breast MRI.
- Women with age >= 18. No ethnic restrictions.
- No life expectancy restrictions.
- Performance status not a factor.
- No requirements for organ or marrow function.
- Ability to understand and the willingness to sign a written informed consent document.\

Who cannot join
- Patient is unable to complete a breast MRI due to such factors as hardware and claustrophobia.
- No limitations as to other investigational agents. Patients who have received neoadjuvant chemotherapy will not be included in the study due to the limitations of MRI interpretation after neoadjuvant chemotherapy and because this represents a distinct scenario for interpretation of breast MRI in comparison with untreated patients.
- There are no comorbidities that would preclude entry into the study unless the patient is unable to lay still for breast MRI scanning.
- There are fewer reactions to MRI contrast media, but if there is such a history, the patient will be excluded from consideration.
- There are no exclusion criteria based on concomitant medications.
- There are no other agent specific exclusion criteria.
- Pregnancy is considered a contraindication given the uncertain effects of breast MRI on the fetus.
- Cancer survivors are candidates for the study unless the patient has a prior ipsilateral breast tumor.
About this study
Official title: Randomized Trial of Breast MRI in Women With Newly Diagnosed Breast Cancer Prior to Breast Conserving Surgery
To see if performing breast MRI before a lumpectomy will help the surgeon successfully remove the entire cancer with normal tissue margins in a single operation thereby reducing the need for additional surgical procedures. The study will also measure how well MRI can find unsuspected cancers in the same breast as the known cancer; how well MRI will find unsuspected cancers in the opposite breast; how often MRI will generate false positive MRI findings; whether routinely incorporating breast MRI delays care or adds unnecessary cost; and, whether breast MRI is able to reduce the frequency of cancer recurrence in the treated breast or elsewhere in the body.
- Conditions
- Breast Cancer
- Being tested
- Breast 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.
Breast MRIProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether pre-lumpectomy breast MRI reduces the frequency of repeat lumpectomy in women with DCIS < 5 cm or T1 or T2 invasive breast cancer
Secondary outcomes (12)
To determine how often MRI will detect occult multifocal or multicentric disease
To determine how often MRI will miss occult DCIS or invasive cancer subsequently detected on surgical pathology
To determine the frequency with which breast MRI changes the surgical plan
To determine the frequency of false positive MRI findings requiring biopsy
To measure whether MRI reduces the frequency of repeat lumpectomy to a greater extent in women with mammographically dense vs fatty breasts
To measure whether preoperative MRI is associated with enhanced postoperative cosmesis
To measure whether preoperative MRI alters cost of care
To measure the degree and extent to which preoperative MRI lengthens the time required to deliver care
To measure whether preoperative MRI increases the rate of patient directed ("unnecessary") mastectomy
To measure whether MRI decreases the risk of ipsilateral breast tumor recurrence
To measure disease-free survival without/with preoperative breast MRI
To measure overall survival without/with preoperative MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
Why it stopped: PI
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 Stanford UniversityThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederick M. Dirbas, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695916
- Sponsor's protocol ID
- BRSNSTU0025
- Other IDs
- 98272, BRSNSTU0025, NCT00695916, 6125
- Status last verified
- Jan 2017
- First submitted
- 10 Jun 2008
- Last updated
- 1 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Breast MRI in Women With Newly Diagnosed Breast Cancer Prior to Breast Conserving Surgery
- ClinicalTrials.gov ID
- NCT00695916
- Acronym / sponsor ID
- BRSNSTU0025
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- First posted
- 12 Jun 2008 (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.
To see if performing breast MRI before a lumpectomy will help the surgeon successfully remove the entire cancer with normal tissue margins in a single operation thereby reducing the need for additional surgical procedures. The study will also measure how well MRI can find unsuspected cancers in the same breast as the known cancer; how well MRI will find unsuspected cancers in the opposite breast; how often MRI will generate false positive MRI findings; whether routinely incorporating breast MRI delays care or adds unnecessary cost; and, whether breast MRI is able to reduce the frequency of cancer recurrence in the treated breast or elsewhere in the body.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- DCIS less than 5 cm. T1/T2 invasive breast cancer. Patient is a suitable candidate for breast conservation and wishes this as the primary clinical approach
- No breast MRI within the past year. Prior core biopsy, but no prior excision allowed. Patient has completed conventional imaging workup with mammography ultrasound as indicated and there is no clinical indication for breast MRI.
- Women with age >= 18. No ethnic restrictions.
- No life expectancy restrictions.
- Performance status not a factor.
Key exclusion criteria (8 listed)
- Patient is unable to complete a breast MRI due to such factors as hardware and claustrophobia.
- No limitations as to other investigational agents. Patients who have received neoadjuvant chemotherapy will not be included in the study due to the limitations of MRI interpretation after neoadjuvant chemotherapy and because this represents a distinct scenario for interpretation of breast MRI in comparison with untreated patients.
- There are no comorbidities that would preclude entry into the study unless the patient is unable to lay still for breast MRI scanning.
- There are fewer reactions to MRI contrast media, but if there is such a history, the patient will be excluded from consideration.
- There are no exclusion criteria based on concomitant medications.
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 |
|---|---|---|
| Breast MRI | Procedure or surgery | – |
Primary outcome
To determine whether pre-lumpectomy breast MRI reduces the frequency of repeat lumpectomy in women with DCIS < 5 cm or T1 or T2 invasive breast cancer
12 secondary outcomes
To determine how often MRI will detect occult multifocal or multicentric disease
To determine how often MRI will miss occult DCIS or invasive cancer subsequently detected on surgical pathology
To determine the frequency with which breast MRI changes the surgical plan
To determine the frequency of false positive MRI findings requiring biopsy
To measure whether MRI reduces the frequency of repeat lumpectomy to a greater extent in women with mammographically dense vs fatty breasts
To measure whether preoperative MRI is associated with enhanced postoperative cosmesis
To measure whether preoperative MRI alters cost of care
To measure the degree and extent to which preoperative MRI lengthens the time required to deliver care
To measure whether preoperative MRI increases the rate of patient directed ("unnecessary") mastectomy
To measure whether MRI decreases the risk of ipsilateral breast tumor recurrence
To measure disease-free survival without/with preoperative breast MRI
To measure overall survival without/with preoperative MRI
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 1 Feb 2017.
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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.
Frederick M. Dirbas principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Breast MRI in people with Breast Cancer, run by Stanford University.
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 7 inclusion and 8 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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
To determine whether pre-lumpectomy breast MRI reduces the frequency of repeat lumpectomy in women with DCIS < 5 cm or T1 or T2 invasive breast cancer. 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 1 Feb 2017.