Breast CancerNCT01297231
Prospective Analysis of Changes in Background Parenchymal Enhancement (BPE) and Amount of Fibroglandular Tissue on Breast MRI
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center.
Trial summary
Tamoxifen is a hormonal treatment for breast cancer. It prevents recurrent disease and decreases death. Tamoxifen is given to women with and at high risk for breast cancer. These women also commonly have breast MRI to monitor for breast cancer. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MRI
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Feb 2014
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Eligible premenopausal patients with stage 0-3 breast cancer for whom MRI staging is planned will be enrolled.
Who may be able to join
- Females with stage 0-3 breast cancer who have had or are planned to have a breast MRI within 1 year prior to starting tamoxifen
- Premenopausal status is defined as intact ovaries and still menstruating
- Clinical and MRI follow-up planned at MSKCC or MCKCC regional facility
- Willing and able to undergo all study procedures
Who cannot join
- Contraindication to breast MRI (such as non-compatible cardiac pacemakers or intracranial vascular clips, allergy to Gadolinium)
- Bilateral breast cancer or treatment such as:
- History of or planned bilateral breast irradiation
- History of or planned bilateral mastectomy
- Bilateral breast cancer
- History of unilateral mastectomy or radiation treatment with contralateral breast cancer
Show all 12Show fewer
- Taking chemo- or hormonal therapy at the time of the baseline breast MRI
- Estrogen and progesterone receptor negative breast cancer
- GFR less than GFR < 30 mL/min/1.73m2
- Postmenopausal women
- Pregnant and/or nursing women
- Less than 21 years of age
About this study
Official title: Prospective Analysis of Changes in Background Parenchymal Enhancement (BPE) and Amount of Fibroglandular Tissue on Breast MRI in Early Stage Breast Cancer Patients on Tamoxifen
Tamoxifen is a hormonal treatment for breast cancer. It prevents recurrent disease and decreases death. Tamoxifen is given to women with and at high risk for breast cancer. These women also commonly have breast MRI to monitor for breast cancer. Some features of normal breast tissue visible on breast MRI change depending on patient hormonal status. It has been questioned if hormonal changes due to tamoxifen are seen on breast MRI. Pilot data suggests this is true. If tamoxifen causes changes in normal breast tissue on MRI, more study could be done looking at whether breast MRI could tell us anything about whether tamoxifen is working.
This study is being done to see if tamoxifen changes normal breast tissue on MRI. It will also look at if other factors like taking anti-depressants or gene type have any effect.
- Conditions
- Breast Cancer
- Being tested
- MRI
- Keywords
- fibroglandular tissue, tamoxifen, MRI, Background Parenchymal Enhancement, 10-217
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Baseline Breast-MRI within 1 year before starting tamoxifen (allows for surgery, chemotherapy and radiation before the start of tamoxifen).
During Tamoxifen Treatment:
- Blood will be drawn for CYP2D6 genotype testing. Analysis of samples will be performed internally at MSKCC.
- Follow-up breast MRI after 9-12 months of tamoxifen therapy. In patients whom further breast MRI screening and/or follow-up is clinically indicated, follow-up breast MRIs may be performed within 3 months (before or after) the 2, 3, and 4 year time points during tamoxifen treatment. All breast MRIs will be performed using the same technique.
- Follow-up for all patients during and after tamoxifen should include routine standard clinical assessment and imaging such as mammography and breast MRI when clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer | This prospective study will recruit patients with stage 0-3 breast cancer who have had or are scheduled for a breast MRI prior to treatment. Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the level of BPE on breast MRI
on breast MRI in premenopausal patients with breast cancer before and during 9-12 months on tamoxifen to determine whether tamoxifen results in a significant decrease in BPE and/or amount of fibroglandular tissue
Measured: 3 years
Secondary outcomes (1)
To compare the amount of fibroglandular tissue on breast MRI
on breast MRI in premenopausal patients with breast cancer before and during 9-12 months on tamoxifen to determine whether tamoxifen results in a significant decrease in BPE and/or amount of fibroglandular tissue
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Why it stopped: Lack of funding
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 Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valencia King, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297231
- Sponsor's protocol ID
- 10-217
- Other IDs
- Mskcc 10-217
- Status last verified
- Nov 2012
- First submitted
- 14 Feb 2011
- Last updated
- 14 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Changes in Background Parenchymal Enhancement (BPE) and Amount of Fibroglandular Tissue on Breast MRI in Early Stage Breast Cancer Patients on Tamoxifen
- ClinicalTrials.gov ID
- NCT01297231
- Acronym / sponsor ID
- 10-217
- Conditions
- Breast Cancer
- Keywords
- fibroglandular tissue, tamoxifen, MRI, Background Parenchymal Enhancement, 10-217
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 16 Feb 2011 (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.
Tamoxifen is a hormonal treatment for breast cancer. It prevents recurrent disease and decreases death. Tamoxifen is given to women with and at high risk for breast cancer. These women also commonly have breast MRI to monitor for breast cancer. Some features of normal breast tissue visible on breast MRI change depending on patient hormonal status. It has been questioned if hormonal changes due to tamoxifen are seen on breast MRI. Pilot data suggests this is true. If tamoxifen causes changes in normal breast tissue on MRI, more study could be done looking at whether breast MRI could tell us anything about whether tamoxifen is working.
This study is being done to see if tamoxifen changes normal breast tissue on MRI. It will also look at if other factors like taking anti-depressants or gene type have any effect.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer | – | Other: MRIThis prospective study will recruit patients with stage 0-3 breast cancer who have had or are scheduled for a breast MRI prior to treatment. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible premenopausal patients with stage 0-3 breast cancer for whom MRI staging is planned will be enrolled.
Key inclusion criteria (4 listed)
- Females with stage 0-3 breast cancer who have had or are planned to have a breast MRI within 1 year prior to starting tamoxifen
- Premenopausal status is defined as intact ovaries and still menstruating
- Clinical and MRI follow-up planned at MSKCC or MCKCC regional facility
- Willing and able to undergo all study procedures
Key exclusion criteria (12 listed)
- Contraindication to breast MRI (such as non-compatible cardiac pacemakers or intracranial vascular clips, allergy to Gadolinium)
- Bilateral breast cancer or treatment such as:
- History of or planned bilateral breast irradiation
- History of or planned bilateral mastectomy
- Bilateral breast 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 |
|---|---|---|
| MRIBaseline Breast-MRI within 1 year before starting tamoxifen (allows for surgery, chemotherapy and radiation before the start of tamoxifen). During Tamoxifen Treatment: * Blood will be drawn for CYP2D6 genotype testing. Analysis of samples will be performed internally at MSKCC. * Follow-up breast MRI after 9-12 months of tamoxifen therapy. In patients whom further breast MRI screening and/or follow-up is clinically indicated, follow-up breast MRIs may be performed within 3 months (before or after) the 2, 3, and 4 year time points during tamoxifen treatment. All breast MRIs will be performed using the same technique. * Follow-up for all patients during and after tamoxifen should include routine standard clinical assessment and imaging such as mammography and breast MRI when clinically indicated. | Other | Breast cancer |
Primary outcome
To compare the level of BPE on breast MRI
Time frame: 3 years
on breast MRI in premenopausal patients with breast cancer before and during 9-12 months on tamoxifen to determine whether tamoxifen results in a significant decrease in BPE and/or amount of fibroglandular tissue
1 secondary outcome
To compare the amount of fibroglandular tissue on breast MRI
Time frame: 3 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 14 Nov 2012.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Valencia King, MD principal investigator
Memorial Sloan Kettering Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center.
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 4 inclusion and 12 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 14 Nov 2012. 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.
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 compare the level of BPE on breast MRI (time frame: 3 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 14 Nov 2012.