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Protocol No. A011104

Principal Investigator Wilke, Lee

Phase N/A

Age Group Adult

Scope National

Sponsor Type National

Title Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women with Breast Cancer

Objective Breast tumors are routinely evaluated using mammograms and ultrasound before surgery. This study would like to find out if using MRI (magnetic resonance imaging) in addition to mammography before surgery improves our ability to evaluate tumors and decide what kind of surgery is best for the patient. The goals of this study are:
  • To see if using MRI improves decision-making when choosing what type of surgery is best for the patient (mastectomy or lumpectomy)
  • To see if using MRI affects how well patients do after surgery
  • To examine the effect of using MRI on patients' quality of life
  • To examine the effect of MRI on overall medical costs

Description You will be randomly assigned (like flipping a coin) or "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. Neither you nor your doctor can choose the group you will be in. You will have an equal chance of being placed in either group.

If you are in Group 1 (often called "Arm 1"), you will have breast conserving surgery (also called "lumpectomy"). If randomized to this "Arm", you will not undergo an MRI before surgery. Surgery will be planned using other imaging you have had done. If you are in Group 2 (often called "Arm 2"), you will have a breast MRI before surgery. Based on the results of the MRI, you and your doctor will decide which type of surgery - lumpectomy or mastectomy - is best for you, and then you will have surgery. Click here for more info

Key Eligibility
  • Patients must be female
  • Patients must have confirmed diagnosis of breast cancer, clinical stage I-II. Diagnosis must be by needle biopsy; patients diagnosed by surgical excision are excluded
  • Patients must have ER negative/PR negative and HER-2 negative breast cancer
  • Patients must not have a known BRCA mutation

Applicable Disease Sites Breast

Therapies Involved Other

Status Open

Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park