Trial Outcomes & Findings for Retinoid 9cUAB30 in Producing a Biologic Effect in Patients With Early Stage Breast Cancer (NCT NCT02876640)
NCT ID: NCT02876640
Last Updated: 2024-06-18
Results Overview
Ki-67 was analyzed using immunohistochemistry. Absolute change was measured in looking at the baseline in comparison to that at the end of treatment.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Baseline up to 28 days (post-exposure)
Results posted on
2024-06-18
Participant Flow
Participant milestones
| Measure |
Treatment (Retinoid 9cUAB30)
Patients receive retinoid 9cUAB30 PO QD for 14 to 28 days. Patients then undergo tumor resection surgery. Patients undergo blood and urine sample collection throughout the study.
Biospecimen Collection: Undergo blood and urine sample collection
Retinoid 9cUAB30: Given PO
Therapeutic Conventional Surgery: Undergo tumor resection surgery
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
3 of the cancers were estrogen receptor negative
Baseline characteristics by cohort
| Measure |
Treatment (Retinoid 9cUAB30)
n=27 Participants
Patients receive retinoid 9cUAB30 PO QD for 14 to 28 days. Patients then undergo tumor resection surgery. Patients undergo blood and urine sample collection throughout the study.
Biospecimen Collection: Undergo blood and urine sample collection
Retinoid 9cUAB30: Given PO
Therapeutic Conventional Surgery: Undergo tumor resection surgery
|
|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=27 Participants
|
|
Age, Customized
18-64 years
|
14 Participants
n=27 Participants
|
|
Age, Customized
>=65 years
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=27 Participants
|
|
Body Mass Index
|
29.97 kg/m^2
STANDARD_DEVIATION 6.95 • n=27 Participants
|
|
Respirations
|
15.74 breaths per minute
STANDARD_DEVIATION 1.65 • n=27 Participants
|
|
Menopausal Status
Pre-menopausal
|
3 Participants
n=27 Participants
|
|
Menopausal Status
Post-menopausal
|
24 Participants
n=27 Participants
|
|
Time from Diagnosis to study Entry
|
32.85 days
STANDARD_DEVIATION 19.14 • n=27 Participants
|
|
Breast Cancer Location
Left Breast
|
13 Participants
n=27 Participants
|
|
Breast Cancer Location
Right Breast
|
14 Participants
n=27 Participants
|
|
Breast Cancer Biology
Invasive Lobular Carcinoma
|
4 Participants
n=27 Participants
|
|
Breast Cancer Biology
Invasive Ductal Carcinoma
|
20 Participants
n=27 Participants
|
|
Breast Cancer Biology
Invasive Mammary Carcinoma
|
3 Participants
n=27 Participants
|
|
Estrogen Receptor Status
Negative
|
3 Participants
n=27 Participants
|
|
Estrogen Receptor Status
Positive
|
24 Participants
n=27 Participants
|
|
HER2 IHC Result
0
|
14 Participants
n=22 Participants • 3 of the cancers were estrogen receptor negative
|
|
HER2 IHC Result
1+
|
5 Participants
n=22 Participants • 3 of the cancers were estrogen receptor negative
|
|
HER2 IHC Result
2+
|
2 Participants
n=22 Participants • 3 of the cancers were estrogen receptor negative
|
|
HER2 IHC Result
3+
|
1 Participants
n=22 Participants • 3 of the cancers were estrogen receptor negative
|
|
Estrogen Receptor Score
|
85.96 percentage
STANDARD_DEVIATION 31 • n=27 Participants
|
|
HER2 FISH
Equivocal
|
1 Participants
n=27 Participants
|
|
HER2 FISH
No result/not done not amplified
|
26 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 28 days (post-exposure)Population: One participant's sample did not have any tumor tissue to be analyzed
Ki-67 was analyzed using immunohistochemistry. Absolute change was measured in looking at the baseline in comparison to that at the end of treatment.
Outcome measures
| Measure |
Treatment (Retinoid 9cUAB30)
n=26 Participants
Patients receive retinoid 9cUAB30 PO QD for 14 to 28 days. Patients then undergo tumor resection surgery. Patients undergo blood and urine sample collection throughout the study.
Biospecimen Collection: Undergo blood and urine sample collection
Retinoid 9cUAB30: Given PO
Therapeutic Conventional Surgery: Undergo tumor resection surgery
|
|---|---|
|
Absolute Change in Ki-67 Expression in Breast Epithelial Cells of Patients Treated With 9cUAB30
|
0.2 Percent of cells
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline up to 28 days (post-exposure)Population: One participant's sample did not have any tumor tissue to analyze
Will be assessed by caspase 3 assays 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.
Outcome measures
| Measure |
Treatment (Retinoid 9cUAB30)
n=26 Participants
Patients receive retinoid 9cUAB30 PO QD for 14 to 28 days. Patients then undergo tumor resection surgery. Patients undergo blood and urine sample collection throughout the study.
Biospecimen Collection: Undergo blood and urine sample collection
Retinoid 9cUAB30: Given PO
Therapeutic Conventional Surgery: Undergo tumor resection surgery
|
|---|---|
|
Change in Apoptosis in Breast Epithelial Cells of Patients Treated With 9cUAB30
|
0.62 percent of cells
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: Baseline up to 28 days (post-exposure)Change in gene expression will be summarized with descriptive statistics.
Outcome measures
| Measure |
Treatment (Retinoid 9cUAB30)
n=27 Participants
Patients receive retinoid 9cUAB30 PO QD for 14 to 28 days. Patients then undergo tumor resection surgery. Patients undergo blood and urine sample collection throughout the study.
Biospecimen Collection: Undergo blood and urine sample collection
Retinoid 9cUAB30: Given PO
Therapeutic Conventional Surgery: Undergo tumor resection surgery
|
|---|---|
|
Change in Gene Expression of Breast Cancer Samples Using a Custom Gene Panel From Nanostring Technologies
Up regulated IL6 expression
|
9.49 % of protein
Interval 4.85 to 18.6
|
|
Change in Gene Expression of Breast Cancer Samples Using a Custom Gene Panel From Nanostring Technologies
Down regulated CDKN2A expression
|
0.34 % of protein
Interval 0.254 to 0.617
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, and 2 hours post-doseWill be tested by a one-sided one-sample student t-test.
Outcome measures
| Measure |
Treatment (Retinoid 9cUAB30)
n=27 Participants
Patients receive retinoid 9cUAB30 PO QD for 14 to 28 days. Patients then undergo tumor resection surgery. Patients undergo blood and urine sample collection throughout the study.
Biospecimen Collection: Undergo blood and urine sample collection
Retinoid 9cUAB30: Given PO
Therapeutic Conventional Surgery: Undergo tumor resection surgery
|
|---|---|
|
Change in Maximum Concentration (Cmax)
|
990.7 ng/mL
Standard Error 312.9
|
SECONDARY outcome
Timeframe: Up to 28 daysWill be graded according to Common Terminology Criteria for Adverse Events version 4.0. Will be compared to know retinoid toxicity. These will be described in descriptive statistics and analyzed.
Outcome measures
| Measure |
Treatment (Retinoid 9cUAB30)
n=27 Participants
Patients receive retinoid 9cUAB30 PO QD for 14 to 28 days. Patients then undergo tumor resection surgery. Patients undergo blood and urine sample collection throughout the study.
Biospecimen Collection: Undergo blood and urine sample collection
Retinoid 9cUAB30: Given PO
Therapeutic Conventional Surgery: Undergo tumor resection surgery
|
|---|---|
|
Incidence of Observed Adverse Events
|
128 number of adverse events
|
SECONDARY outcome
Timeframe: Baseline up to 28 days (post-exposure)Population: 19 patients had matched pre and post samples
Outcome measures
| Measure |
Treatment (Retinoid 9cUAB30)
n=19 Participants
Patients receive retinoid 9cUAB30 PO QD for 14 to 28 days. Patients then undergo tumor resection surgery. Patients undergo blood and urine sample collection throughout the study.
Biospecimen Collection: Undergo blood and urine sample collection
Retinoid 9cUAB30: Given PO
Therapeutic Conventional Surgery: Undergo tumor resection surgery
|
|---|---|
|
Change in Activated Type I Dendritic Cells in Peripheral Blood
type 1 CD40+mDCs
|
0.12 percent of cells
Standard Deviation 0.22
|
|
Change in Activated Type I Dendritic Cells in Peripheral Blood
CD86+ mDCs
|
1.0 percent of cells
Standard Deviation 8.71
|
|
Change in Activated Type I Dendritic Cells in Peripheral Blood
type 1 CD86+ macrophages
|
-0.15 percent of cells
Standard Deviation 0.26
|
|
Change in Activated Type I Dendritic Cells in Peripheral Blood
HLADR+ pDCs
|
-6.42 percent of cells
Standard Deviation 12.11
|
|
Change in Activated Type I Dendritic Cells in Peripheral Blood
CD33+CD11b+HLA DR+ CD40+ cells
|
0.26 percent of cells
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Baseline up to 28 days (post-exposure)Population: Data was not collected
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Retinoid 9cUAB30)
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Retinoid 9cUAB30)
n=27 participants at risk
Patients receive retinoid 9cUAB30 PO QD for 14 to 28 days. Patients then undergo tumor resection surgery. Patients undergo blood and urine sample collection throughout the study.
Biospecimen Collection: Undergo blood and urine sample collection
Retinoid 9cUAB30: Given PO
Therapeutic Conventional Surgery: Undergo tumor resection surgery
|
|---|---|
|
Gastrointestinal disorders
constipation
|
7.4%
2/27 • 28 days
|
|
Gastrointestinal disorders
diarrhea
|
14.8%
4/27 • 28 days
|
|
Gastrointestinal disorders
dry mouth
|
7.4%
2/27 • 28 days
|
|
Gastrointestinal disorders
nausea
|
7.4%
2/27 • 28 days
|
|
General disorders
fatigue
|
37.0%
10/27 • 28 days
|
|
General disorders
malaise
|
7.4%
2/27 • 28 days
|
|
Injury, poisoning and procedural complications
venous injury
|
7.4%
2/27 • 28 days
|
|
Investigations
cholesterol high ldl
|
18.5%
5/27 • 28 days
|
|
Investigations
Cholesterol non-hdl high
|
22.2%
6/27 • 28 days
|
|
Investigations
white blood cell decreased
|
7.4%
2/27 • 28 days
|
|
Metabolism and nutrition disorders
hypertriglyceridemia
|
7.4%
2/27 • 28 days
|
|
Musculoskeletal and connective tissue disorders
back pain
|
7.4%
2/27 • 28 days
|
|
Nervous system disorders
headache
|
29.6%
8/27 • 28 days
|
|
Skin and subcutaneous tissue disorders
dry skin
|
7.4%
2/27 • 28 days
|
|
Skin and subcutaneous tissue disorders
pruritis
|
11.1%
3/27 • 28 days
|
|
Skin and subcutaneous tissue disorders
rash acneiform
|
14.8%
4/27 • 28 days
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
7.4%
2/27 • 28 days
|
|
Vascular disorders
hypertension
|
51.9%
14/27 • 28 days
|
|
Investigations
Cholesterol high
|
22.2%
6/27 • 28 days
|
Additional Information
Lisa Barroilhet, MD, MS
University of Wisconsin - Madison
Phone: 608-264-3204
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60