Retinoid 9cUAB30 in Producing a Biologic Effect in Patients With Early Stage Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02876640|
Recruitment Status : Recruiting
First Posted : August 24, 2016
Last Update Posted : November 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Early-Stage Breast Carcinoma Invasive Breast Carcinoma||Drug: Retinoid 9cUAB30 Procedure: Therapeutic Conventional Surgery||Phase 1|
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) to demonstrate significantly reduced proliferation.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib 9cUAB30 in Early Stage Breast Cancer to Evaluate Biologic Effect|
|Actual Study Start Date :||March 16, 2018|
|Estimated Primary Completion Date :||February 1, 2022|
|Estimated Study Completion Date :||February 1, 2022|
Experimental: Treatment (retinoid 9cUAB30)
Patients receive retinoid 9cUAB30 PO QD for 14 to 28 days. Patients then undergo tumor resection surgery.
Drug: Retinoid 9cUAB30
Other Name: 9cUAB30
Procedure: Therapeutic Conventional Surgery
Undergo tumor resection surgery
- Absolute change in Ki-67 expression in breast epithelial cells of patients treated with 9cUAB30 [ Time Frame: Baseline up to 28 days (post-exposure) ]Will be assessed by immunohistochemistry. The baseline, post-exposure, absolute change in Ki-67, and difference in absolute change between the treated and matched controls will all be summarized with descriptive statistics. The primary analysis will compare the difference in absolute change in Ki-67 between treatment and matched "control" group using a one-tailed paired t-test or Wilcoxon signed-rank test, as appropriate, at a significance level of 0.05.
- Change in apoptosis in breast epithelial cells of patients treated with 9cUAB30 [ Time Frame: Baseline up to 28 days (post-exposure) ]Will be assessed by TUNEL assay and immunohistochemistry. Change between the treated and matched controls will be summarized with descriptive statistics. Difference in apoptosis will be compared between treatment and matched "control" group using a one-tailed paired t-test or Wilcoxon signed-rank test, as appropriate, at a significance level of 0.05.
- Change in gene expression of breast cancer samples using a custom gene panel from Nanostring Technologies [ Time Frame: Baseline up to 28 days (post-exposure) ]Change in gene expression will be summarized with descriptive statistics.
- Change in maximum concentration (Cmax) [ Time Frame: Baseline up to day 1 ]Will be tested by a one-sided one-sample student t-test.
- Incidence of observed adverse events [ Time Frame: Up to 28 days ]Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Will be compared to know retinoid toxicity. These will be described in descriptive statistics and analyzed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876640
|United States, Alabama|
|University of Alabama at Birmingham Cancer Center||Recruiting|
|Birmingham, Alabama, United States, 35233|
|Contact: Helen Krontiras 205-934-3028 firstname.lastname@example.org|
|Principal Investigator: Helen Krontiras|
|United States, Iowa|
|University of Iowa/Holden Comprehensive Cancer Center||Not yet recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Sonia L. Sugg 319-356-7675 email@example.com|
|Principal Investigator: Sonia L. Sugg|
|United States, Minnesota|
|University of Minnesota/Masonic Cancer Center||Not yet recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Jane Yuet Ching Hui 612-625-2991 firstname.lastname@example.org|
|Principal Investigator: Jane Yuet Ching Hui|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Lee G. Wilke 608-265-5852 email@example.com|
|Principal Investigator: Lee G. Wilke|
|Principal Investigator:||Helen Krontiras||University of Wisconsin, Madison|