Retinoid 9cUAB30 in Producing a Biologic Effect in Patients With Early Stage Breast Cancer

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PRIMARY OBJECTIVE: I. Compare molecular analysis of pre- and post-treatment tissue samples of breast cancers of patients treated with 14-28 days of oral retinoid X receptor (RXR)-selective retinoid 9cUAB30 (9 cUAB30) will demonstrate significantly reduced proliferation. SECONDARY OBJECTIVES: I. Dete...

PRIMARY OBJECTIVE: I. Compare molecular analysis of pre- and post-treatment tissue samples of breast cancers of patients treated with 14-28 days of oral retinoid X receptor (RXR)-selective retinoid 9cUAB30 (9 cUAB30) will demonstrate significantly reduced proliferation. SECONDARY OBJECTIVES: I. Determine if 14-28 days of oral RXR-selective 9c-UAB30 treatment increases apoptotic index, as measured by TdT-mediated dUTP nick end labeling (TUNEL) assay. II. Examine the differences in gene expression from baseline to post-exposure breast cancer samples using a custom gene panel from Nanostring Technologies. III. To examine if the maximum concentration (Cmax) and safety of 9cUAB30 in the first 5 participants is affected by reducing the number of capsules at the 240 mg dose level. IV. To examine the Cmax of all participants at baseline and on the day of surgery. V. Determine if treatment with 2-4 weeks of 9cUAB30 prior to surgery will increase activated type I dendritic cells in peripheral blood. VI. Determine if treatment with 2-4 weeks of 9cUAB30 prior to surgery will increase gene expression of type I immune cells in the tumor immune environment of all participants except the first 5. VII. Assess the overall safety of 9cUAB30 in comparison with known retinoid toxicity. OUTLINE: Patients receive retinoid 9cUAB30 orally (PO) once daily (QD) for 14 to 28 days. Patients then undergo tumor resection surgery. After completion of study treatment, patients are followed up at 7 days and 4-5 weeks.

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