Trial Outcomes & Findings for Neoadjuvant Propanolol in Breast Cancer (NCT NCT02596867)
NCT ID: NCT02596867
Last Updated: 2018-03-01
Results Overview
to evaluate effect of beta adrenergic blockades on breast cancer at by Ki67 percentage change- we are looking at at least 10% mean change in the tumor proliferative index following propranolol treatment
TERMINATED
PHASE2
2 participants
3 weeks
2018-03-01
Participant Flow
Prospective - two breast cancer patients enrolled over 6 months perios from clinic .
Participant milestones
| Measure |
Open Label Single Arm, Drug Propanolol
2 subjects enrolled and received the experimental drug propanolol: Participants took 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
2 Patients Prospectively Recruited
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Propanolol in Breast Cancer
Baseline characteristics by cohort
| Measure |
Open Label Single Arm, Drug Propanolol
n=2 Participants
2 subjects enrolled and received the experimental drug
propanolol: Participants took 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=99 Participants
|
|
Tumor response by Ki 67
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: Two patients with breast cancer are included in this analysis. One patient was a stage I breast cancer and the second patient was a stage III breast cancer.
to evaluate effect of beta adrenergic blockades on breast cancer at by Ki67 percentage change- we are looking at at least 10% mean change in the tumor proliferative index following propranolol treatment
Outcome measures
| Measure |
Open Label Single Arm, Drug Propanolol
n=2 Participants
We tested the efficacy of propranolol on two patients with breast cancer by recording % reduction of Ki67
|
|---|---|
|
Evaluate the Effect of the Beta Blocker Propranolol on Reducing the Tumor Proliferative Index Using Ki-67.
Stage I Patient 1
|
23 % mean difference of Ki67
|
|
Evaluate the Effect of the Beta Blocker Propranolol on Reducing the Tumor Proliferative Index Using Ki-67.
Stage III Patient 2
|
66 % mean difference of Ki67
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Two patients with breast cancer are included in this analysis. One patient was a stage I breast cancer and the second patient was a stage III breast cancer, AEs were assessed during and after treatment
Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.(Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4)
Outcome measures
| Measure |
Open Label Single Arm, Drug Propanolol
n=2 Participants
We tested the efficacy of propranolol on two patients with breast cancer by recording % reduction of Ki67
|
|---|---|
|
Assess the Safety, Toxicity and Adherence to Propranolol.
|
0 Participants
|
Adverse Events
Open Label Single Arm, Drug Propanolol
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place