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Protocol No. UW16063
Principal Investigator Wilke, Lee
Phase I (Cancer Control)
Age Group Adult
Sponsor Type Externally Peer-Reviewed
Title Phase Ib 9cUAB30 in Early Stage Breast Cancer to Evaluate Biologic Effect
Objective The purpose of this study is to determine if the study drug called 9cUAB30 has an effect on growth of cancer cells. 9cUAB30 is an investigational drug that has been shown in animals to prevent breast cancers. We will be looking to see if there are any changes in the breast cancer cells that may indicate that the study drug could be used in the future to help prevent breast cancer. We will also be looking at the level of 9cUAB30 in the blood of the first six participants.
Treatment All women enrolled in this study will receive the study drug 9cUAB30 by mouth daily for 14-28 days. You should take the study medication at bedtime at least two hours after last eating. After taking your study medication, you must wait an hour before eating anything. The first 6 participants will receive 240mg daily and additional blood draws to test the level of drug absorbed in the blood. If the 240 mg dose of 9cUAB30 does not provide a higher level of drug in the bloodstream than was observed after 160mg in our prior study, then the remaining participants will receive 160mg daily. Women treated with 9cUAB30 in this study will have their tumor biopsy and surgical samples compared to leftover tumor biopsy or surgical samples from women with similar stages of breast cancer, but not treated with 9cUAB30 to determine if 9cUAB30 reduced breast cancer cell growth or not in treated women
Description Phase 1b, looking at 9cUAB30 which is a novel rexinoid for chemoprevention.
Female patients 18 years of age or older
ECOG performance status less than or equal to 1, KPS greater than or equal to 70%
Invasive breast cancer between 0.5 cm and 5 cm in size diagnosed by needle core biopsy, ER+ or ER, Her2neu positive or negative, Tumor grade 2 or 3.
Normal organ and bone marrow function
Must agree to discontinue all vitamin supplements while taking study medication and for thirty days after the last dose of study medication
No prior treatment with chemotherapy, biological therapy or breast radiotherapy.
No prior use of tamoxifen, raloxifene, or other antiestrogen compounds.
No prior use of exogenous hormone replacement therapy or oral contraception in the year prior to diagnosis. The use of non-systemic estrogen (such as vaginal estrogen use) is allowed.
Only postmenopausal women and some premenopausal women
Can not be taking lipid lowering agents
Can not be HIV positive, no active infection, no symptomatic congestive heart failure, no unstable angina, no cardiac arrhythmia's, no persistent grade 3 hypertension.
No prior second malignancies unless greater than 5 years
Core biopsy must have sufficient tumor to adequately evaluate for Ki67 and TUNEL assays
Applicable Disease Sites Breast
Participating Institutions UW Hospital and Clinics