Trial Outcomes & Findings for Effect of Vandetanib on Cellular Markers in Invasive Breast Cancer (NCT NCT01934335)
NCT ID: NCT01934335
Last Updated: 2021-11-01
Results Overview
Pre- and post-treatment samples will be assessed by immunohistochemistry for positivity for Ki-67.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
2 weeks
Results posted on
2021-11-01
Participant Flow
Participant milestones
| Measure |
Vandetanib
Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery
Vandetanib
|
Placebo
Placebo, PO, q day for 7-14 days prior to surgery.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Vandetanib
Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery
Vandetanib
|
Placebo
Placebo, PO, q day for 7-14 days prior to surgery.
Placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Effect of Vandetanib on Cellular Markers in Invasive Breast Cancer
Baseline characteristics by cohort
| Measure |
Vandetanib
n=7 Participants
Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery
Vandetanib
|
Placebo
n=5 Participants
Placebo, PO, q day for 7-14 days prior to surgery.
Placebo
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
55.5 years
n=5 Participants
|
62.9 years
n=7 Participants
|
58.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: 10 subjects took study drug and completed surgery
Pre- and post-treatment samples will be assessed by immunohistochemistry for positivity for Ki-67.
Outcome measures
| Measure |
Vandetanib
n=6 Participants
Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery
Vandetanib
|
Placebo
n=4 Participants
Placebo, PO, q day for 7-14 days prior to surgery.
Placebo
|
|---|---|---|
|
Percent Change From Baseline in Ki-67 Cells Observed 2 Weeks Post-treatment
|
0.3 percentage of positivity for Ki-67.
Standard Deviation 0.08
|
2 percentage of positivity for Ki-67.
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 10 subjects took study drug and completed surgery
Pre- and post-treatment samples will be assessed by immunohistochemistry for positivity for TUNEL.
Outcome measures
| Measure |
Vandetanib
n=6 Participants
Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery
Vandetanib
|
Placebo
n=4 Participants
Placebo, PO, q day for 7-14 days prior to surgery.
Placebo
|
|---|---|---|
|
Percent Change From Baseline in TUNEL Observed 2 Weeks Post-treatment
|
0.48 percentage of for positivity for TUNEL
Standard Deviation 0.71
|
1.02 percentage of for positivity for TUNEL
Standard Deviation 89
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeksPopulation: 6 patients that got the study drug and completed surgery by RET expression were analyzed
Results will be stratified by RET gene expression, a negative prognostic indicator in breast cancer, to demonstrate that RET is a marker of response.
Outcome measures
| Measure |
Vandetanib
n=3 Participants
Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery
Vandetanib
|
Placebo
n=3 Participants
Placebo, PO, q day for 7-14 days prior to surgery.
Placebo
|
|---|---|---|
|
Percent Change From Baseline in RET Expression Observed 2 Weeks Post-treatment
Ki-67
|
-0.3 percent change of RET positive samples
Standard Deviation 0.03
|
1.0 percent change of RET positive samples
Standard Deviation 0.12
|
|
Percent Change From Baseline in RET Expression Observed 2 Weeks Post-treatment
TUNEL
|
0.77 percent change of RET positive samples
Standard Deviation 0.32
|
0.2 percent change of RET positive samples
Standard Deviation 0.12
|
Adverse Events
Vandetanib
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vandetanib
n=6 participants at risk
Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery
Vandetanib
|
Placebo
n=5 participants at risk
Placebo, PO, q day for 7-14 days prior to surgery.
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • 4 months
|
0.00%
0/5 • 4 months
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • 4 months
|
20.0%
1/5 • Number of events 1 • 4 months
|
|
General disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • 4 months
|
0.00%
0/5 • 4 months
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
3/6 • Number of events 3 • 4 months
|
0.00%
0/5 • 4 months
|
|
Nervous system disorders
Paresthesia
|
16.7%
1/6 • Number of events 1 • 4 months
|
0.00%
0/5 • 4 months
|
|
Eye disorders
Blurred vision
|
16.7%
1/6 • Number of events 1 • 4 months
|
0.00%
0/5 • 4 months
|
|
General disorders
Hot flashes
|
16.7%
1/6 • Number of events 1 • 4 months
|
0.00%
0/5 • 4 months
|
|
Metabolism and nutrition disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1 • 4 months
|
0.00%
0/5 • 4 months
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Number of events 1 • 4 months
|
0.00%
0/5 • 4 months
|
|
Eye disorders
Itchy eyes
|
16.7%
1/6 • Number of events 1 • 4 months
|
0.00%
0/5 • 4 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Number of events 1 • 4 months
|
0.00%
0/5 • 4 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1 • 4 months
|
0.00%
0/5 • 4 months
|
Additional Information
Ronald Weigel, MD, PhD
Holden Comprehensive Cancer Center
Phone: 319-353-7474
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place