Assessing Response to Neoadjuvant Chemotherapy With HD PET/CT, Serum Glycomic Markers and Tissue Muc-1 Isoforms

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

A pilot study of adult (≥ 18 years) women with stage II-III breast cancer who will receive preoperative chemotherapy prior to mastectomy. Patients will have real-time serum glycan profiling, expression of tissue MUC 1 oncoprotein isoforms to predict neoadjuvant chemotherapy response and additional mammography and HD PET/CT examinations to assess response. The investigators hypothesize that a functional tumor assessment utilizing high-definition positron emission tomography/computed tomography (HD PET/CT), real-time serum glycan profiling, and expression of tissue MUC 1 oncoprotein isoforms will predict neoadjuvant chemotherapy response in breast cancer patients.

Key facts

Study ID

NCT01110174

Run by

University of California, Davis

People needed

8

Starts

2010-03-01

Expected to finish

2016-03-01

Last updated by the study team

2019-11-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.