Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer (ACRIN 6657)
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.
Radiation: gadopentetate dimeglumine
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Contrast-Enhanced Breast MRI For Evaluation Of Patients Undergoing Neoadjuvant Treatment For Locally-Advanced Breast Cancer (I-SPY 1/ACRIN 6657)|
- Disease-free three-year survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Extent of residual disease [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Change in the maximum dimension of the tumor over time [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Change in the tumor volume over time [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Maximum dimension of tumor size measure by MRI, mammography, and pathology [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- MRI volume [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- MRI peak signal enhancement ratio (SER) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- SER distribution (percent of tumor in highest SER category) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Morphological pattern [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Change in tumor size by clinical exam [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2002|
|Study Completion Date:||March 2011|
|Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
MRI and MRS examinations with standard imaging, with contrast enhancement using an agent (gadopentetate dimeglumine).
Serial MRI studies evaluated for prognostic properties related to therapeutic response.
Other Names:Radiation: gadopentetate dimeglumine
Imaging agent used for contrast enhancement in each of the MRIs.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00043017
|United States, Alabama|
|UAB Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Minnesota|
|Masonic Cancer Center at University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Mayo Clinic Cancer Research Consortium|
|Rochester, Minnesota, United States, 55905|
|United States, New Hampshire|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390-9085|
|Study Chair:||Nola M. Hylton, PhD||University of California, San Francisco|