Breast Cancer, Cancer of the Breast
Conditions
Keywords
Dense breasts, Abbreviated MRI, Risk assessment
Brief summary
Recent research has shown that, among women with extremely dense breasts and normal results on mammogram, magnetic resonance imaging (MRI) use has significantly reduced the occurrence of breast cancer that is diagnosed during the time between two regular screening mammograms (also known as interval cancers). The investigators have developed and validated an approach to use the whole mammogram image, develop a mammogram risk score (MRS), and calibrate this to the SEER breast cancer incidence rates for US women. This model (Prognosia Breast) generates an absolute 5-year risk of breast cancer and classifies approximately 5.7% of the population as high risk using the ASCO 3% cut point as used for endocrine therapy to reduce risk. Follow-up generates an incidence of 25.2 cases per 1,000 women per year.
Interventions
DEVICEPrognosia Breast
The risk output from this algorithm is calibrated to US Surveillance, Epidemiology, and End Results (SEER) 5-year risk and so estimates for each woman the personal 5-year risk.
DEVICEMammogram
Standard of care annual screening mammogram
DEVICEMRI
MRI at the time of annual screening mammogram
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
The feasibility study will enroll 78 evaluable women and will be sequential enrollment. The sample size for the randomized controlled portion of this study will depend on the results of the feasibility portion of the study and it will be parallel enrollment.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal screening mammogram within 90 days prior to enrollment. * Dense breasts, either: * Class C density ("the breasts are heterogeneously dense, which may obscure small masses") * Class D density ("the breasts are extremely dense, which lowers the sensitivity of mammography") * MRS risk estimate at \> 3% 5-year risk of breast cancer. * Female. * Between 25 and 55 years of age (inclusive). * Ability to understand and willingness to sign an IRB approved written informed consent document.
Exclusion criteria
* More than 1 prior mammogram * Contraindication to MRI with contrast (e.g. claustrophobia, metal objects in the body, known sensitivity/allergy to gadolinium). * Prior or concurrent malignancy whose natural history has the potential to interfere with the study intervention (breast cancer or LCIS). Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial. * Prior MRI screening of the breast. * Known to be BRCA 1/2 positive or presence of any other known high penetrance genetic marker. * Is receiving any chemoprevention. * Has breast implants. * Is breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of successful recommendations for MRI (Feasibility portion only) | Through completion of follow-up (estimated to be 24 months) | Successful recommendation of MRI is defined as completion of MRI by women referred for MRI. |
| 2-year detection rate (Randomized Controlled Trial only) | 2 years | Events including interval breast cancer or invasive breast cancer of a size ≥15mm or being lymph node positive, by arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sample size for randomized controlled trial (Feasibility portion only) | Through completion of follow-up (estimated to be 24 months) | At the completion of the feasibility study, the investigators will use the feasibility study data to inform and calculate the sample size for the subsequent randomized 2-arm trial, and if feasible and results are promising, the investigators will propose a randomized 2-arm trial to evaluate the effectiveness of MRI screening in terms of 2-year event rate. |
| Number and percentage of recalls (Feasibility portion only) | Through completion of follow-up (estimated to be 24 months) | — |
| Positive predictive value for recall for additional testing and biopsy (Feasibility portion only) | Through completion of follow-up (estimated to be 24 months) | — |
| Number and percentage of recalls (Randomized Controlled Trial only) | Through completion of follow-up (estimated to be 24 months) | — |
| Positive predictive value for recall for additional testing and biopsy (Randomized Controlled Portion only) | Through completion of follow-up (estimated to be 24 months) | — |
Countries
United States
Contacts
CONTACTTabassum Ahmad, M.D.
CONTACTGraham A Colditz, M.D., DrPH
PRINCIPAL_INVESTIGATORTabassum Ahmad, M.D.
Washington University School of Medicine
Outcome results
None listed