NCT02876640

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

Phase Ib 9cUAB30 in Early Stage Breast Cancer to Evaluate Biologic Effect

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 1b trial studies the biologic effect of 9cUAB30 on early stage breast cancer. 9cUAB30 is a retinoid X receptor (RXR)-selective retinoid that acts in a tissue selective manner with the goal of minimizing side effects, a necessary feature of agents under development for cancer prevention.

Detailed description

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 cleaved caspase 3 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 gene expression of type I immune cells in the tumor immune environment of all participants except the first 5. VI. Assess the overall safety of 9cUAB30 in comparison with known retinoid toxicity. EXPLORATORY OBJECTIVE: I. Determine if treatment with 2-4 weeks of 9cUAB30 prior to surgery will increase activated type I dendritic cells in peripheral blood. OUTLINE: Patients receive retinoid 9cUAB30 orally (PO) once daily (QD) for 14 to 28 days. Patients then undergo tumor resection surgery. Patients undergo blood and urine sample collection throughout the study. After completion of study treatment, patients are followed up at 7 days and 4-5 weeks.

Conditions

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage IA Breast Cancer AJCC v8
• Anatomic Stage IB Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage IIA Breast Cancer AJCC v8
• Anatomic Stage IIB Breast Cancer AJCC v8
• Breast Ductal Carcinoma In Situ
• Early Stage Breast Carcinoma
• Invasive Breast Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood and urine sample collection
DRUG	Retinoid 9cUAB30	Given PO
PROCEDURE	Therapeutic Conventional Surgery	Undergo tumor resection surgery

Timeline

• Start date: 2018-03-16
• Primary completion: 2022-06-03
• Completion: 2022-06-03
• First posted: 2016-08-24
• Last updated: 2024-06-18
• Results posted: 2024-05-22

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study