RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may help determine the effectiveness of chemotherapy in killing breast cancer and allow doctors to plan more effective treatment. PURPOSE: Diagnostic trial to study the effectiveness of MRI in monitoring tumor response in women who are receiving chemotherapy for stage III breast cancer.
OBJECTIVES: * 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
356
Serial MRI studies evaluated for prognostic properties related to therapeutic response.
Imaging agent used for contrast enhancement in each of the MRIs.
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Disease-free three-year survival
Time frame: 3 years
Extent of residual disease
Time frame: 3 years
Change in the maximum dimension of the tumor over time
Time frame: 3 years
Change in the tumor volume over time
Time frame: 3 years
Maximum dimension of tumor size measure by MRI, mammography, and pathology
Time frame: 3 years
MRI volume
Time frame: 3 years
MRI peak signal enhancement ratio (SER)
Time frame: 3 years
SER distribution (percent of tumor in highest SER category)
Time frame: 3 years
Morphological pattern
Time frame: 3 years
Change in tumor size by clinical exam
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Washington D.C., District of Columbia, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Research Consortium
Rochester, Minnesota, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
...and 1 more locations