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About
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.
Full 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).
Secondary objectives are:
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.
Enrollment
Sex
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Volunteers
Inclusion and exclusion 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; patients diagnosed by surgical excision are excluded.
Patients 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:
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
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 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.
Suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow):
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
≥ 18 years of age
Signed study-specific informed consent prior to registration
Primary purpose
Allocation
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317 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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