MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01805076|
Recruitment Status : Active, not recruiting
First Posted : March 6, 2013
Last Update Posted : January 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Estrogen Receptor-negative Breast Cancer Progesterone Receptor-negative Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer Triple-negative Breast Cancer||Procedure: Breast surgery Procedure: Magnetic resonance imaging Procedure: Mammography||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||317 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer|
|Actual Study Start Date :||February 2014|
|Estimated Primary Completion Date :||February 2025|
Arm 1 (control)
Patients undergo a clinical breast examination and mammography with ultrasound of the breast and regional nodes followed by breast conserving surgery.
Procedure: Breast surgery
Experimental: 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.
Procedure: Breast surgery
Procedure: Magnetic resonance imaging
- Local-regional recurrence (LRR) [ Time Frame: Up to 5 years ]
- Re-operation rate [ Time Frame: Up to 5 years ]
- Conversion rate to mastectomy secondary to persistent positive margins or poor cosmesis [ Time Frame: Within the first 6 months ]
- Time to contralateral breast cancer [ Time Frame: Up to 5 years post-randomization ]
- Disease-free survival (DFS) [ Time Frame: Up to 5 years post-randomization ]
- Overall survival [ Time Frame: Up to 5 years post-randomization ]
- Breast cancer specific survival will be measured [ Time Frame: Up to 5 years post-randomization ]
- Rate of MRI-guided localization assisted surgery (Arm B) [ Time Frame: Up to 5 years ]
- False positive rate for MRI detection of multiple disease foci [ Time Frame: Up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805076
|Study Chair:||Isabelle Bedrosian, MD||M.D. Anderson Cancer Center|