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MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer
Overall Recruitment Status: Active, enrollment completed
Official Title
Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer
Region Sponsors
Alliance for Clinical Trials in Oncology
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Acronym KP IRB No.
Study Type Phase
Clinical Trial Phase III
Study Population Description
Patients undergoing breast surgery
The purpose of this study is to test whether patients undergoing a breast MRI (magnetic resonance imaging) before breast surgery will have better results after the surgery. Breast tumors are routinely evaluated using mammograms and ultrasound before surgery. This study would like to find out if using MRI in addition to mammography before surgery improves our ability to evaluate tumors and decide what kind of surgery is best for the patient.
Detailed Description
This is a randomized trial of preoperative breast MRI in patients deemed eligible for breast conserving surgery by conventional clinical criteria will provide important information about the clinical and biologic relevance of occult disease identified by MRI alone. Patients will be assigned to standard pre-operative breast cancer disease assessment without the addition of MRI prior to breast conserving surgery or standard pre-operative breast cancer disease assessment with the use of MRI prior to breast conserving surgery. The primary objective is to compare the rates of local-regional recurrence (LRR) following attempted breast conserving therapy in a cohort of women with triple negative or HER-2 amplified breast cancer randomized to preoperative staging with mammography (control arm) or mammography plus breast MRI (MRI arm). All registered patients will be monitored for relapse and survival for 5 years from the date of surgery. Patients will be followed a minimum of every 4 months for the first 2 years from diagnosis and a minimum of every 6 months during years 3-5. Patients will be monitored for local, regional, distant relapse and vital status.
Gender Age Limit
Inclusion Criteria
  • Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0, T0-2 N1 M0). Diagnosis must be by needle biopsy - patients diagnosed by surgical excision are excluded
  • No patients with previous ipsilateral invasive breast cancer or ductal carcinoma in situ (DCIS)
  • No patients with bilateral breast cancer
  • No patients with known deleterious mutations in breast cancer (BRCA) genes
  • No current history of receiving hormonal therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures
  • No history of chemotherapy for cancer within 6 months prior to registration
  • No patients scheduled to receive neoadjuvant chemotherapy or partial breast irradiation following breast conserving surgery
Exclusion Criteria
  • Patients with multicentric or multifocal disease scheduled to undergo multiple lumpectomies. Multifocal disease that can be encompassed in a single operative bed can be enrolled
  • Prior MRI of study breast within the 12 months prior to registration

Keywords and/or Specific Medical Conditions
  • Progesterone Receptor-negative Breast Cancer
  • Oncology (Adult)
  • Stage IA
  • Stage IB
  • Estrogen Receptor-negative Breast Cancer
  • Stage II
  • Magnetic resonance imaging
  • Triple-negative Breast Cancer
  • MRI
KP Clinical Facility
  • Burke Medical Center
  • Capitol Hill Medical Center
  • Gaithersburg Medical Center
  • Largo Medical Center
  • Tyson's Corner Medical Center
  • Woodlawn Medical Center
Clinical Area
  • Oncology (Adult)

Principal Investigator:
Amadea Tette, MD
Contact Information:
- Diane Fisher
-Burke Medical Center

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