Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 319
- 试验地点
- 355
- 主要终点
- Local-regional recurrence (LRR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Arm 1 (control)
Patients undergo a clinical breast examination and mammography with ultrasound of the breast and regional nodes followed by breast conserving surgery.
干预措施: Breast surgery (Procedure)
Arm 1 (control)
Patients undergo a clinical breast examination and mammography with ultrasound of the breast and regional nodes followed by breast conserving surgery.
干预措施: Mammography (Procedure)
Arm 2 (experimental)
Patients undergo a clinical breast examination, mammography with ultrasound of breast and regional nodes and breast MRI followed by breast conserving surgery or mastectomy.
干预措施: Magnetic resonance imaging (Procedure)
Arm 2 (experimental)
Patients undergo a clinical breast examination, mammography with ultrasound of breast and regional nodes and breast MRI followed by breast conserving surgery or mastectomy.
干预措施: Mammography (Procedure)
Arm 2 (experimental)
Patients undergo a clinical breast examination, mammography with ultrasound of breast and regional nodes and breast MRI followed by breast conserving surgery or mastectomy.
干预措施: Breast surgery (Procedure)
结局指标
主要结局
Local-regional recurrence (LRR)
时间窗: Up to 5 years
Local-regional Recurrence (LRR)
时间窗: Up to 5 years
次要结局
- Conversion rate to mastectomy secondary to persistent positive margins or poor cosmesis(Within the first 6 months)
- Disease-free survival (DFS)(Up to 5 years post-randomization)
- Breast cancer specific survival will be measured(Up to 5 years post-randomization)
- Rate of MRI-guided localization assisted surgery (Arm B)(Up to 5 years)
- Time to contralateral breast cancer(Up to 5 years post-randomization)
- Overall survival(Up to 5 years post-randomization)
- False positive rate for MRI detection of multiple disease foci(Up to 5 years)
- Re-operation rate(Up to 5 years)
- Overall Survival(Up to 5 years post-randomization)
- Re-operation Rate(Up to 5 years)
- Conversion Rate to Mastectomy Secondary to Persistent Positive Margins or Poor Cosmesis(Within the first 6 months)
- Time to Contralateral Breast Cancer(Up to 5 years post-randomization)
- Disease-free Survival (DFS)(Up to 5 years post-randomization)
- Breast Cancer Specific Survival Will be Measured(Up to 5 years post-randomization)
- Rate of MRI-guided Localization Assisted Surgery (Arm B)(Up to 5 years)
- False Positive Rate for MRI Detection of Multiple Disease Foci(Up to 5 years)