Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Procedure: MRI/MRSRadiation: gadopentetate dimeglumine
- Registration Number
- NCT00043017
- Lead Sponsor
- American College of Radiology Imaging Network
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 356
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MRI/MRS gadopentetate dimeglumine MRI and MRS examinations with standard imaging, with contrast enhancement using an agent (gadopentetate dimeglumine). MRI/MRS MRI/MRS MRI and MRS examinations with standard imaging, with contrast enhancement using an agent (gadopentetate dimeglumine).
- Primary Outcome Measures
Name Time Method Disease-free three-year survival 3 years
- Secondary Outcome Measures
Name Time Method Change in the maximum dimension of the tumor over time 3 years Change in the tumor volume over time 3 years Maximum dimension of tumor size measure by MRI, mammography, and pathology 3 years Extent of residual disease 3 years MRI volume 3 years MRI peak signal enhancement ratio (SER) 3 years Morphological pattern 3 years Change in tumor size by clinical exam 3 years SER distribution (percent of tumor in highest SER category) 3 years
Trial Locations
- Locations (11)
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
UAB Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Mayo Clinic Cancer Research Consortium
🇺🇸Rochester, Minnesota, United States
Masonic Cancer Center at University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States