A Study of the Effect of Using MRI and Mammography Before Surgery in Patients with Stage I-II Breast Cancer

Overview

About this study

The purpose of this study is to assess 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 the ability to evaluate tumors and decide what kind of surgery is best for the patient.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Female
    • Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer
  • Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0, T0-2 N1 M0)
  • Diagnosis must be by needle biopsy
    • Diagnosis by surgical excision is excluded
  • Must have either
    • Estrogen receptor (ER) negative/progesterone receptor (PR) negative (< 10% by immunohistochemistry IHC staining) and HER-2 negative breast cancer OR
    • ER negative/PR negative (< 10% by IHC staining) and HER-2 positive tumors
      • HER-2 status will be determined as per the 2013 ASCO CAP guidelines
        • HER-2 is considered positive if there is IHC 3+ staining or ISH positive using either single probe ISH or dual probe ISH
        • HER-2 is considered negative if there is IHC 0 or 1+ staining or ISH negative using either single probe ISH or dual probe ISH
  • No  previous ipsilateral invasive breast cancer or ductal carcinoma in situ (DCIS)
  • No  bilateral breast cancer
  • No  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 scheduled neoadjuvant chemotherapy or partial breast irradiation following breast conserving surgery
  • Eligible for BCT based on clinical examination, mammography and, if standard practice at a given institution, ultrasound and/or tomogram
    • Women who cannot be appropriately selected for BCT based on these standard imaging studies, and for whom additional imaging is recommended to clarify local disease extent, will not be eligible for this trial.
  • No multicentric or multifocal disease scheduled to undergo multiple lumpectomies
    • Multifocal disease that can be encompassed in a single operative bed can be enrolled
  • Suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow)
    • No history of untreatable claustrophobia
    • No presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)
    • No history of sickle cell disease
    • No contraindication to intravenous contrast administration
    • No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR)
      • May be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance
    • No findings consistent with renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m^2 based on a creatinine level obtained within 28 days prior to registration
    • Weight lower than that allowable by the MRI table
  • No prior MRI of study breast within the 12 months prior to registration
  • Non-pregnant and non-lactating
  • Patients of child-bearing potential must have a negative pregnancy test within 7 days prior to registration
  • Perimenopausal patients must be amenorrheic > 12 months to be considered not of child-bearing potential

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

James Jakub, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20193930

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