Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02352883
Study type Interventional
Source Eastern Cooperative Oncology Group
Contact
Status Active, not recruiting
Phase N/A
Start date March 25, 2015
Completion date November 2027

See also
  Status Clinical Trial Phase
Completed NCT02314156 - Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy Phase 2
Completed NCT01874184 - Group-Based Lifestyle Intervention in Measuring Biomarker Levels in Participants at High Risk for Breast Cancer N/A
Completed NCT01869764 - Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer Phase 2
Completed NCT02587663 - Extent of Breast Cancer and the Role of Pre-Operative Sonography and MRI N/A
Active, not recruiting NCT04537312 - Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM) N/A
Active, not recruiting NCT01245712 - Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer Phase 2
Recruiting NCT02993159 - Testing an Active Form of Tamoxifen (4-hydroxytamoxifen) Delivered Through the Breast Skin to Control Ductal Carcinoma in Situ (DCIS) of the Breast Phase 2
Completed NCT01753908 - Broccoli Sprout Extract in Treating Patients With Breast Cancer Early Phase 1
Terminated NCT02023008 - Interactive Gentle Yoga in Improving Quality of Life in Patients With Stage I-III Breast Cancer Undergoing Radiation Therapy N/A
Completed NCT01849250 - Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors Phase 2
Terminated NCT01754519 - Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery Phase 2
Completed NCT01819233 - Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy N/A
Active, not recruiting NCT03077841 - Hypofractionated Partial Breast Irradiation in Treating Patients With Early Stage Breast Cancer Phase 2/Phase 3
Recruiting NCT03909282 - Surgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma N/A
Completed NCT01723943 - Educational Counseling in Improving Communication and Quality of Life in Spouses and Breast Cancer Patients N/A
Completed NCT00637481 - A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer Phase 1
Completed NCT01975363 - Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer N/A
Active, not recruiting NCT03391388 - 3D-CRT, Proton, or Brachytherapy APBI in Treating Patients With Invasive and Non-invasive Breast Cancer Phase 2
Completed NCT02526498 - Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery Phase 2
Completed NCT01219075 - Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer N/A