Trial Information

Contrast-Enhanced Breast MRI For Evaluation Of Patients Undergoing Neoadjuvant Treatment For Locally-Advanced 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.

PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study within 3 years.