Preoperative Breast MRI Impact on Surgical Outcomes, Costs and Quality of Life in Breast Cancer Patients
This study aims to evaluate the impact of preoperative breast MRI on surgical outcomes, specifically focusing on local-regional recurrence (LRR) in breast cancer patients.
Breast surgery
+ Mammography
+ Breast surgery
Breast Diseases+4
+ Neoplasms
+ Neoplasms by Site
Diagnostic Study
Summary
Study start date: May 21, 2014
Actual date on which the first participant was enrolled.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: * To compare the re-operation rates following attempted breast conserving therapy between women assessed preoperatively with breast MRI to those assessed without the use of breast MRI * To compare local recurrence rates between women who undergo BCT on the control arm to women who undergo BCT on the MRI arm * To compare the conversion rate to mastectomy secondary to persistent positive margins or poor cosmesis within the first 6 months of attempting BCT (prior to the administration of RT) between women assessed preoperatively with breast MRI to those assessed without the use of breast MRI * To compare the contralateral breast cancer rates in women randomized to preoperative breast MRI to those not receiving pre-operative breast MRI * To compare the disease-free survival rates between women assessed preoperatively with breast MRI to those assessed without the use of breast MRI * To compare breast cancer specific and overall survival outcomes of women assessed preoperatively with breast MRI to those assessed without the use of breast MRI * To estimate the rate of MRI-guided localization assisted surgery * To estimate the rate of multi-centric disease in the index breast for women in the MRI arm * To evaluate the accuracy of index lesion characteristics and other factors in predicting multi-centricity in the cohort randomized to breast MRI * To assess the positive predictive values (PPV) of MRI in detecting ipsilateral multi-centric disease and contralateral disease in women with breast cancer undergoing preoperative breast MRI * To estimate the false positive rate for detection of multiple foci of breast cancer by MRI 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.319 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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: * 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 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 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); patient 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 * ≥ 18 years of age * Signed study-specific informed consent prior to registration
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Group II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 179 locations
Banner MD Anderson Cancer Center
Gilbert, United StatesOpen Banner MD Anderson Cancer Center in Google MapsBaptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, United StatesKaiser Permanente-Deer Valley Medical Center
Antioch, United StatesEnloe Medical Center
Chico, United States