Clinical trial NCT03664778: Abbreviated Breast MRI After Cancer Treatment
Official title: Cancer Detection Rate of Abbreviated (Fast) Breast MRI (AB-MR) After Negative Digital Breast Tomosynthesis in Women Status Post Conservation Therapy (BCT)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Neoplasms
Carcinoma, Intraductal, Noninfiltrating
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who have had primary breast cancer treated with breast conservation therapy and who fit the inclusion criteria listed below.

Brief summary: 500 patients will be prospectively recruited to undergo a fast breast MRI examination. The women will be recruited for the study will meet the following criteria: 1. status post primary breast cancer treated with breast conservation therapy 3 years prior to recruitment 2. negative DBT examination six months prior to recruitment 3. all breast densities 4. clinically asymptomatic - no palpable masses, focalthickening, or clinically significant discharge We will identify these patients EPIC database utilizing the date of their last mammogram. The patients will be sent a letter explaining the study and the opportunity to enroll in the study. Interested patients may contact our research coordinators by the phone number provided in the letter. The study recruitment information will also be shared with referring physicians. Physicians may also directly refer patients to the study.

Detailed description: Women treated for primary breast cancer who undergo breast conservation therapy face an increased risk of developing a second breast cancer in the ipsilateral and the contralateral breast. Although mammographic screening is recommended annually, the sensitivity of mammography is limited in these patients due to the post treatment changes from previous surgery and radiation. We propose supplemental screening with an abbreviated form of breast MRI ("fast MRI") examination in addition to mammographic screening, in order to study whether we can detect subclinical disease that may not be detected on mammography or on physical examination. Several tumor characteristics correlate with overall survival such as the extent of local recurrence and the size of the local recurrence, with larger extent and increased size of local recurrence correlating with adverse survival. In addition, the shorter time interval to the ipsilateral breast cancer recurrence from completion of treatment, is associated with increased risk of developing distant metastasis and breast cancer mortality. We will assess additional cancer detection with fast MRI after negative mammography in the ipsilateral as well as the contralateral breast. The goal of the supplemental screening with fast breast MRI would be to detectsubclinical disease not detected on mammography and thus improve patient outcomes.

Eligibility criteria: Inclusion Criteria:

1. Status post primary breast cancer (both invasive and DCIS) treated with breast conservation therapy at least three years prior to recruitment
2. Negative DBT examination within six months prior to recruitment
3. All breast densities
4. Clinically asymptomatic - no palpable masses or focal thickening, etc.

Exclusion Criteria:

1. Patients who are pregnant or lactating.
2. Patients who have not had a mammogram (digital breast tomosynthesis) in the past 6 months.
3. Patients who are unwilling or unable to provide written informed consent.
4. Patients symptomatic for breast disease (e.g. experiencing discharge, lumps, etc.).
5. Recent breast surgery in the past two years including breast enhancements (e.g. implants or injections) benign surgical biopsies.
6. Patients who are unable to receive an MRI with Gadolinium contrast.
7. Patients who have not had an MRI of the breast within the past year.

Primary outcomes:
measure: Invasive breast cancer detection
timeFrame: 4 years
Secondary outcomes:
measure: DCIS and invasive cancer detection rate
timeFrame: 4 years
measure: Tumor size
timeFrame: 4 years
measure: Axillary nodal status
timeFrame: 4 years
measure: Time to recurrence
timeFrame: 4 years
measure: Ipsilateral and contralateral breast cancer detection
timeFrame: 4 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: UPenn
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Susan Weinstein, MD
role: PRINCIPAL_INVESTIGATOR
References: