Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer
Recruitment status was Recruiting
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.
Procedure: magnetic resonance imaging
Radiation: gadopentetate dimeglumine
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||Contrast-Enhanced Breast MRI For Evaluation Of Patients Undergoing Neoadjuvant Treatment For Locally-Advanced Breast Cancer|
- Disease-free three-year survival [ Designated as safety issue: No ]
- Extent of residual disease [ Designated as safety issue: No ]
- Change in the maximum dimension of the tumor over time [ Designated as safety issue: No ]
- Change in the tumor volume over time [ Designated as safety issue: No ]
- Maximum dimension of tumor size measure by MRI, mammography, and pathology [ Designated as safety issue: No ]
- MRI volume [ Designated as safety issue: No ]
- MRI peak signal enhancement ratio (SER) [ Designated as safety issue: No ]
- SER distribution (percent of tumor in highest SER category) [ Designated as safety issue: No ]
- Morphological pattern [ Designated as safety issue: No ]
- Change in tumor size by clinical exam [ Designated as safety issue: No ]
|Study Start Date:||May 2002|
|Estimated Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
- 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.
|United States, Alabama|
|UAB Comprehensive Cancer Center||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Clinical Trials Office - UAB Comprehensive Cancer Center 205-934-0309|
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222|
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center||Recruiting|
|Washington, District of Columbia, United States, 20007|
|Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center 202-444-0381|
|United States, Illinois|
|University of Chicago Cancer Research Center||Recruiting|
|Chicago, Illinois, United States, 60637-1470|
|Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424|
|United States, Minnesota|
|Masonic Cancer Center at University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620|
|Mayo Clinic Cancer Research Consortium||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Clinical Trials Office - Mayo Clinic Cancer Research Consortiu 507-538-7623|
|United States, New Hampshire|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Recruiting|
|Lebanon, New Hampshire, United States, 03756-0002|
|Contact: Clinical Trials Office - Norris Cotton Cancer Center 603-650-7609 firstname.lastname@example.org|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Elizabeth Morris 212-639-2236|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892|
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Recruiting|
|Dallas, Texas, United States, 75390-9085|
|Contact: Paul Weatherall, MD 214-684-3711|
|Study Chair:||Nola M. Hylton, PhD||University of California, San Francisco|