Prospective Study of Magnetic Resonance Imaging (MRI) and Multiparameter Gene Expression Assay in Ductal Carcinoma In Situ (DCIS)

Brief Summary

Detailed Description

PRIMARY OBJECTIVES: I. To estimate the proportion of patients with ductal carcinoma in situ (DCIS) diagnosed on core needle biopsy judged to be breast conservation candidates based upon standard imaging (mammography +/- sonography) and physical examination (a) who convert to mastectomy in step 1 based on MRI findings, and (b) who have a mastectomy as the final surgical procedure in step 2. SECONDARY OBJECTIVES: I. To assess the relation between baseline clinical covariates (e.g., tumor grade, necrosis, histologic type, mammographic lesion size), MRI morphologic and kinetic features, and the DCIS score. II. To assess the diagnostic accuracy of MRI in extent of disease evaluation in patients with DCIS. III. To estimate the proportion of patients who require re-operation because of inadequate excision after MRI. IV. To estimate the proportion of patients who proceed to mastectomy after an initial attempt at wide local excision because of either inadequate tumor-free margins (\< 2 mm), or other reasons. V. To estimate the 5-year and 10-year ipsilateral breast event (in situ and invasive) rate (IBE) among women with DCIS assessed with MRI preoperatively and treated with wide local excision without radiation therapy (if there is a low DCIS score) or with radiation therapy (if there is an intermediate-high DCIS score). VI. To estimate the proportion of women with DCIS who receive treatment that is concordant with their treatment goals and concerns. VII. To estimate the proportion of women with DCIS whose decision autonomy preference was concordant with perceived level of decision involvement. VIII. To assess decision quality using knowledge score and decision process. IX. To assess concordance between decision autonomy preference and perceived level of decision involvement, knowledge and decision process scores as independent predictors of decision satisfaction at the first post-operative visit. X. To assess the relationship of patient-reported outcomes and disease-specific covariates, and quality of life after treatment. XI. To assess the role of disease status, diagnostic test results and surgeon recommendation as predictors of treatment received. XII. To compare the patient-reported diagnostic testing burden of bilateral mammography and MRI as measured by Testing Morbidities Index (TMI). OUTLINE: STEP 1: ARM A: Patients undergo MRI prior to surgery. Patients undergo additional imaging and/or biopsies if indicated based on MRI. STEP 2: Patients are assigned to 1 of 2 treatment arms based on the results of the MRI. ARM B: Patients undergo a mastectomy. Patients do not register for Step 3. ARM C: Patients undergo wide local excision +/- re-excision. Patients may cross-over to Arm B if mastectomy is indicated. Tissue samples collected during surgery are used to calculate the DCIS score using genetic analysis testing. Patients may then proceed to Step 3. STEP 3: Patients are assigned to 1 of 2 treatment arms based on the results of the DCIS score test. ARM D (DCIS score \< 39): Patients undergo endocrine therapy as directed. ARM E (DCIS score \>= 39): Patients undergo radiation therapy and endocrine therapy as directed. After completion of study treatment, patients are followed up every 6 months for 5 years and then every 12 months for 5 years.

Primary Outcomes

Secondary Outcomes

• Factors associated with DCIS score(After surgery (DCIS Score is determined from surgical specimen))
• Proportion of patients who proceed to mastectomy after an initial attempt at wide local excision because of either inadequate tumor-free margins (< 2mm), or other reasons(Up to 12 months post-op)
• IBE rate(At 10 years)
• Diagnostic accuracy of MRI in extent of disease evaluation in patients with DCIS(Up to 12 months post-op)
• Proportion of patients who require re-operation because of inadequate excision after MRI(Up to 12 months post-op)
• Proportion of women who receive treatment that is concordant with their treatment goals and concerns(Up to 24 months post-op)
• Decision quality, assessed using the composite of knowledge score and decision process score(Up to 5 days after pre-surgical consultation)
• Patient-reported quality of life, measured using the Patient Reported Outcomes Measurement Information System (PROMIS)10 instrument(At 12 months post-op)
• Role of disease status, diagnostic test results, and surgeon recommendation as predictors of treatment received(Up to 24 months post-op)
• Proportion of women whose decision autonomy preference was concordant with perceived level of decision involvement(Up to 5 days after pre-surgical consultation)
• Role of concordance between decision autonomy preference and perceived level of decision involvement, knowledge and decision process scores as independent predictors of decision satisfaction(Assessed via questionnaire administered at first post-operative visit)
• Patient-reported quality of life, measured using the PROMIS10 instrument(At 24 months post-op)
• Patient-reported diagnostic testing burden of bilateral mammogram, MRI, and biopsies, measured by TMI(Up to 5 days after pre-surgical consultation)