Contrast-Enhanced Breast MRI for Evaluation of Patients Undergoing
Neoadjuvant Treatment for Locally Advanced Breast Cancer
Protocol-ACRIN 6657 Amendment 6, 3.8.10 [PDF]
SOC-ACRIN 6657 Amendment 6, 3.8.10 [PDF]
Informed Consent-ACRIN 6657 [DOC]
Note: the ACRIN 6657 protocol amendment includes an extension to the original protocol to include additional aims as described below.
Principal Investigators: Nola M. Hylton, PhD, ACRIN Principal Investigator
Laura J. Esserman, MD, MBA, CALGB Study Chair
Main Objective: Use MRI measurements of tumor response to uniquely identify two groups of participants who have statistically different three-year disease-free survival out of a group of participants with Stage III breast cancer who demonstrate a partial or minimal clinical response (as identified by physical examination) to neoadjuvant chemotherapy.
The objective of the ACRIN 6657 protocol extension is to investigate the usefulness of total choline concentration [tCho] measured by 1H MRS early in the course of treatment, for predicting pathologic response. Following completion of accrual to the original 6657 protocol, an additional group of patients meeting the same eligibility criteria as in the original protocol are being enrolled to the protocol extension. Three changes to the imaging protocol have been made: 1) addition of a single voxel 1H MRS acquisition and optional diffusion-weighted MRI acquisition to the MRI exam, 2) reduction of the number of (6657 study-related) imaging exams from 4 to 3 during the course of treatment, and 3) change of the timing of the post 1st cycle MRI/MRS exam.
Participants: Participants enrolled in the CALGB/Intergroup trial 49808 or participants receiving neoadjuvant chemotherapy consisting of an anthracyclin based regimen only or followed by a taxane and enrolled in CALGB Correlative Science trial 150007.