Assessing Response to Neoadjuvant Chemotherapy With Dedicated Breast High Definition PET/CT, Serum Glycomic Markers and Tissue Muc-1 Isoforms
This is a non-randomized clinical trial pilot study. Consenting adult (≥ 18 years) women
with stage II-III breast cancer undergoing will receive neoadjuvant chemotherapy with a
standard ACT regimen prior to mastectomy. Prior to beginning chemotherapy, patients will
receive a baseline mammogram, breast HD PET/CT, and blood draw. Not more than 7 days prior
to the second cycle of chemotherapy, patients will have both HD PET/CT and diagnostic
mammography images taken to assess early response to treatment. Patients will have two
additional mammography and HD PET/CT examinations: one after the first cycle of
chemotherapy, and another upon completion of the last cycle of chemotherapy but before
mastectomy. The investigators will collect data on the size (maximum diameter, estimated
volume) and 18FDG uptake (SUV) of the known primary breast cancer on HD PET/CT. Blood will
be sampled from patients at 12 separate time points during the study for glycan analysis.
At least 3 ml will be taken with each blood draw. The first blood draw will be taken when
the patient agrees to enroll in the study. The second blood draw will be taken prior to the
first cycle of chemotherapy. Thereafter, blood will be drawn for serum glycan analysis
after each cycle of chemotherapy is completed. After the patient undergoes mastectomy,
tissue will be collected for MUC-1 assay and two additional blood draws will be taken.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Assess the ability of the HD PET/CT to predict final histopathologic NAC response.
Patients will have a HD PET/CT at baseline and another after the first cycle of NAC and upon completion.The goal is to distinguish NAC responders from non-responders and to accurately identify the size and extent of residual disease.
After the first cycle of Neoadjuvant chemotherapy (NAC)
Steve Martinez, MD
University of California, Davis
United States: Institutional Review Board
|University of California, Davis Medical Center||Sacramento, California|