Human Clinical Protocols of the UAB SPORE in Breast Cancer

A phase I study of radiolabeled DOTA-biotin localization of tumor pretargeted by murine CC49 antibody/Streptavidin fusion protein (CC49 fusion) in patients with TAG-72 expressing metastatic or locally advanced gastrointestinal adenocarcinoma (completed accrual and closed) – Dr. A. LoBuglio, Principal Investigator. (This developed from Project #6 of the current UAB Breast SPORE.)

Phase I pretargeted radioimmunotherapy (PRIT) of metastatic breast cancer (awaiting reagents) – Dr. R. Meredith, Principal Investigator. (This developed from Project #6 of the current UAB Breast SPORE.)

A phase II trial of pre-operative Taxol and Carboplatin in women with newly diagnosed operable breast cancer (active) – Dr. L. Nabell, Principal Investigator. (This developed as part of a developmental Research project.)

Ductal lavage as a potential breast cancer detection device (active) – Dr. H. Krontiras, Principal Investigator. (This developed as part of a developmental research project.)

Contrast-enhanced breast MRI and correlative science studies to characterize tumor response in patients undergoing neoadjuvant treatment for locally advanced breast cancer (active) – Dr. H. Krontiras, Sub-site Principal Investigator; Dr. L. Esserman (UCSF Breast SPORE), Principal Investigator. (This is a formal NCI-sponsored inter-SPORE collaboration.)

Surrogate endpoints in prevention studies and ductal lavage (active) – Dr. H. Krontiras, Sub-site Principal Investigator; Dr. S. Khan (Northwestern Breast SPORE), Principal Investigator. (This is a formal NCI-sponsored inter-SPORE collaboration.)

A phase II trial of OSI-774 (Tarceva), a HER (erbB) tyrosine kinase inhibitor, in treatment-naïve operable breast cancer (pending) – Dr. S. Beenken, Sub-site Principal Investigator; Dr. C. Arteaga (Vanderbilt Breast SPORE), Principal Investigator. (This is a formal NCI-sponsored inter-SPORE collaboration.)

Phase I study of CS-1008, in patients with advanced malignancies (pending) – Dr. A. Forero, Principal Investigator. (This comprises part of the Project #5 competitive renewal proposal.)

A phase II open label trial of pre-operative (neoadjuvant) Letrozole (Femara) in combination in post-menopausal women with newly diagnosed operable breast cancer (pending) – Dr. A. Forero, Principal Investigator. (This developed from the original Project #2 of the current UAB Breast SPORE.)

The study of Avastin (Bevacizumab) to reverse acquired estrogen independence in metastatic breast cancer patients previously responsive to hormonal therapy: A phase II trial (pending activation) – Dr. C. Falkson and Dr. A. Forero, Co-Principal Investigators. (This developed from the original Project #2 of the current UAB Breast SPORE.)