NCT00043017

Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer

Contrast-Enhanced Breast MRI For Evaluation Of Patients Undergoing Neoadjuvant Treatment For Locally-Advanced Breast Cancer (I-SPY 1/ACRIN 6657)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: American College of Radiology Imaging Network · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	MRI/MRS	Serial MRI studies evaluated for prognostic properties related to therapeutic response.
RADIATION	gadopentetate dimeglumine	Imaging agent used for contrast enhancement in each of the MRIs.

Timeline

• Start date: 2002-05-01
• Primary completion: 2005-05-01
• Completion: 2011-03-01
• First posted: 2003-01-27
• Last updated: 2013-10-09

Locations

11 sites across 1 country: United States