Clinical Trial: MRI and Gene Expression in Diagnosing Patients With Ductal Breast Cancer In Situ

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: This clinical trial studies magnetic resonance imaging (MRI) and gene expression in diagnosing patients with abnormal cells in the breast duct that have not spread outside the duct. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. MRI may help find and diagnose patients with breast cancer. It may also help doctors predict a patient's response to treatment and help plan the best treatment. Genetic studies may help doctors predict the outcome of treatment and the risk for disease recurrence. Performing MRI with genetic studies may help determine the best treatment for patients with breast cancer in situ.

Detailed Summary:

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 w
Sponsor: ECOG-ACRIN Cancer Research Group

Current Primary Outcome:

  • Proportion of patients judged to be breast conservation candidates based upon standard imaging and physical examination who convert to mastectomy in step 1 based on MRI findings [ Time Frame: After MRI (within 30 days following study entry), and prior to surgery ]
  • Proportion of patients judged to be breast conservation candidates based upon standard imaging and physical examination who have a mastectomy as the final surgical procedure in step 2 [ Time Frame: Up to 12 months post-op ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Factors associated with DCIS score [ Time Frame: After surgery (DCIS Score is determined from surgical specimen) ]
    The relation between baseline clinical covariates (tumor grade, necrosis, histologic type, mammographic lesion size), MRI morphologic and kinetic features, and the DCIS score will be assessed.
  • Diagnostic accuracy of MRI in extent of disease evaluation in patients with DCIS [ Time Frame: Up to 12 months post-op ]
  • Proportion of patients who require re-operation because of inadequate excision after MRI [ Time Frame: Up to 12 months post-op ]
    A two-sided 95% Wilson confidence interval will be derived.
  • 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 [ Time Frame: Up to 12 months post-op ]
    A two-sided 95% Wilson confidence interval will be derived. In addition to the overall probability of conversion in this cohort, estimates will be stratified by the reason for conversion.
  • IBE rate [ Time Frame: At 5 years ]
    Kaplan-Meier curves will be derived for the time to ipsilateral breast event for patients assigned to be treated with RT and those not treated with RT. Point estimates and 95% two-sided confidence intervals will be developed.
  • IBE rate [ Time Frame: At 10 years ]
    Kaplan-Meier curves will be derived for the time to ipsilateral breast event for patients assigned to be treated with RT and those not treated with RT. Point estimates and 95% two-sided confidence intervals will be developed.
  • Proportion of women who receive treatment that is concordant with their treatment goals and concerns [ Time Frame: Up to 24 months post-op ]
    The proportion of patients with concordant care will be calculated and a 95% Wilson confidence interval will also be derived.
  • Proportion of women whose decision autonomy preference was concordant with perceived level of decision involvement [ Time Frame: Up to 5 days after pre-surgical consultation ]
    Concordance will be defined as an exact match between decision autonomy preference (patient-based, shared, surgeon-based) and perceived level of decision involvement (patient based, shared, surgeon-based) as assessed by the Control Preferences Scale, reduced to three categories. The proportion of patients with concordance will be calculated for the sample. In addition, the degree of concordance over the group will be determined using kappa analysis.
  • Decision quality, assessed using the composite of knowledge score and decision process score [ Time Frame: Up to 5 days after pre-surgical consultation ]
    To calculate knowledge score, a point for each correct answer on the knowledge questionnaire will be assigned, with missing responses receiving 0 points. A total score will be calculated for all patients who complete at least half of the items and scaled from 0-100%. To calculate a decision process score, a point will be assigned for each "yes" or "a lot/some" response. The sum will be scaled from 0-100%. The average of the two scores will be used as the outcome measure.
  • Role of concordance between decision autonomy preference and perceived level of decision involvement, knowledge and decision process scores as independent predictors of decision satisfaction [ Time Frame: Assessed via questionnaire administered at first post-operative visit ]
    Linear regression modeling will be used in which the response variable will be decision satisfaction. The independent variables will be the indicator of concordance between decision autonomy preference and perceived level of decision involvement, the knowledge score and the decision process score. Two-way interactions between predictors will also be examined.
  • Patient-reported quality of life, measured using the Patient Reported Outcomes Measurement Information System (PROMIS)10 instrument [ Time Frame: At 12 months post-op ]
    The relationship of patient-reported outcomes and disease specific covariates, and quality of life will be assessed.
  • Patient-reported quality of life, measured using the PROMIS10 instrument [ Time Frame: At 24 months post-op ]
    The relationship of patient-reported outcomes and disease specific covariates, and quality of life will be assessed.
  • Role of disease status, diagnostic test results, and surgeon recommendation as predictors of treatment received [ Time Frame: Up to 24 months post-op ]
    Logistic regression modeling will be used in which the response variable will be the indicator of conversion to mastectomy (vs lumpectomy). The independent variables will include covariates describing disease status at baseline, MRI results, surgeon recommendation, pa

    Original Secondary Outcome: Same as current

    Information By: Eastern Cooperative Oncology Group

    Dates:
    Date Received: January 16, 2015
    Date Started: March 2015
    Date Completion:
    Last Updated: September 22, 2015
    Last Verified: September 2015