Contrast-Enhanced Breast MRI For Evaluation Of Patients Undergoing Neoadjuvant Treatment For Locally-Advanced Breast Cancer
- Identify surrogate markers of response to neoadjuvant chemotherapy by contrast-enhanced
magnetic resonance imaging (MRI) that are predictive of pathologic remissions and
survival in women with stage III breast cancer.
- Identify two groups of patients who have statistically different 3-year disease-free
survival using MRI measurements of tumor response to neoadjuvant chemotherapy.
- Determine whether MRI measurements of tumor response after the first course of
neoadjuvant chemotherapy can predict which of these patients will ultimately have poor
clinical response to chemotherapy.
- Compare the accuracy of MRI vs mammography in predicting the extent of residual disease
as determined by histopathology in these patients.
- Determine whether initial MRI tumor characteristics (morphologic and vascular patterns)
predict pathological response and/or survival in these patients.
- Estimate the conditional probability of response to paclitaxel based on MRI
measurements of response to doxorubicin and cyclophosphamide in these patients.
OUTLINE: This is a multicenter study.
Patients receive an injection of gadopentetate dimeglumine and undergo magnetic resonance
imaging (MRI) and magnetic resonance spectroscopy of the breast within 4 weeks before
beginning neoadjuvant chemotherapy, 20-28 hours or 48-96 hours after the first course of
doxorubicin and cyclophosphamide (Type 1 chemotherapy), between Type 1 chemotherapy and
paclitaxel chemotherapy regimens (Type 2 chemotherapy) (MRI only) if the patient continues
to Type 2 chemotherapy, and 3-4 weeks after final neoadjuvant chemotherapy treatment (1-2
weeks before surgery).
Patients also undergo mammograms and possibly ultrasounds that coincide with the first and
last MRI. Core or needle biopsy is performed after the first MRI but before the first course
of Type 1 chemotherapy and between Type 1 chemotherapy and Type 2 chemotherapy (if the
patient continues to Type 2 chemotherapy).
Patients are followed every 6 months for 7-10 years.
PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study within 3 years.
Primary Purpose: Diagnostic
Disease-free three-year survival
Nola M. Hylton, PhD
University of California, San Francisco
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756-0002|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center||Washington, District of Columbia 20007|
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|
|UAB Comprehensive Cancer Center||Birmingham, Alabama 35294|
|Mayo Clinic Cancer Research Consortium||Rochester, Minnesota 55905|