Assessing Response to Neoadjuvant Chemotherapy With Dedicated Breast High Definition PET/CT, Serum Glycomic Markers and Tissue Muc-1 Isoforms
18 Years
N/A
Female
Breast Cancer
Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Assess the ability of the HD PET/CT to predict final histopathologic NAC response.
Outcome Description:
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.
Outcome Time Frame:
After the first cycle of Neoadjuvant chemotherapy (NAC)
Safety Issue:
No
Principal Investigator
Steve Martinez, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, Davis
Authority:
United States: Institutional Review Board
Study ID:
200917637
NCT ID:
NCT01110174
Start Date:
March 2010
Completion Date:
April 2013
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| University of California, Davis Medical Center | Sacramento, California |
