Assessing Response to Neoadjuvant Chemotherapy With HD 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.

Inclusion Criteria:

- Patient must sign informed consent to participate in the study.

- Patient must be ≥ 18 years of age.

- Histologic diagnosis of invasive breast cancer(ductal or lobular)

- Stage II or III breast cancer and considered a candidate for curative mastectomy.

- Selected mastectomy for surgical option of treatment.

- Patient must agree to receive standard or dose-dense adriamycin, cyclophosphamide, and
taxane-based chemotherapy given preoperatively.

- Patient must have the following preoperative laboratory values confirmed within 28
days prior to registration: Creatinine ≤ 1.5 times ULN. Platelets ≥ 90,000/mm3. White
blood count ≥ 1,500/mm3. PT/PTT ≤ the institution ULN. Patients of child-bearing
potential must have a negative urine or serum pregnancy test.

- If a patient is a cancer survivor, the patient must have undergone potentially
curative therapy for all prior malignancies, with no evidence of prior malignancy for
at least 5 years (except for effectively treated basal cell or squamous cell carcinoma
of the skin, or carcinoma-in-situ of the cervix treated by surgery alone).

- The primary breast tumor must be detectable by mammogram at the time of diagnosis

- Estimated cardiac ejection fraction ≥ 50% by echocardiogram or MUGA

- ECOG performance status 0-1.

Exclusion Criteria:

- Non-invasive breast cancer, benign breast disease, or tumor histology other than stage
II or stage III invasive ductal carcinoma, invasive lobular carcinoma, or mixed ductal
and lobular carcinoma.

- The patient has known distant metastatic disease.

- The patient wishes to pursue breast conservation.

- The patient is male.

- The patient is receiving preoperative chemotherapy other than adriamycin,
cyclophosphamide, and a taxane (ACT) in standard or dose-dense fashion.

- The patient is pregnant or breast feeding.

- The primary tumor is not visualized by mammogram at the time of diagnosis.

- The patient's estimated cardiac ejection fraction is <50% by echocardiogram or MUGA.

- The patient has a documented intravenous contrast allergy or iodine allergy.

- Her-2/neu positive patients by IHC or FISH who receive trastuzumab neoadjuvantly;
patients who are Her-2/neu positive but elect not to receive trastuzumab neoadjuvantly
are still eligible for participation.