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Neoadjuvant Propanolol in Breast Cancer (NPBC)

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ClinicalTrials.gov Identifier: NCT02596867
Recruitment Status : Terminated (poor accrual)
First Posted : November 4, 2015
Results First Posted : February 1, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Zeina Nahleh, Texas Tech University Health Sciences Center, El Paso

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Drug: propanolol
Enrollment 2
Recruitment Details Prospective - two breast cancer patients enrolled over 6 months perios from clinic .
Pre-assignment Details  
Arm/Group Title Open Label Single Arm, Drug Propanolol
Hide Arm/Group Description 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
Period Title: Overall Study
Started 2
2 Patients Prospectively Recruited 2
Completed 2
Not Completed 0
Arm/Group Title Open Label Single Arm, Drug Propanolol
Hide Arm/Group Description

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 Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
2
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
2
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
 100.0%
Tumor response by Ki 67  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
2
 100.0%
1.Primary Outcome
Title Evaluate the Effect of the Beta Blocker Propranolol on Reducing the Tumor Proliferative Index Using Ki-67.
Hide Description 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
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Open Label Single Arm, Drug Propanolol
Hide Arm/Group Description:
We tested the efficacy of propranolol on two patients with breast cancer by recording % reduction of Ki67
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: % mean difference of Ki67
Stage I Patient 1 Number Analyzed 1 participants
23
Stage III Patient 2 Number Analyzed 1 participants
66
2.Secondary Outcome
Title Assess the Safety, Toxicity and Adherence to Propranolol.
Hide Description Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.(Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4)
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Open Label Single Arm, Drug Propanolol
Hide Arm/Group Description:

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

Both patients reported no AEs due to treatment during treatment phase

Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame AEs were monitored during and at the end of treatment (a total of 3 weeks)
Adverse Event Reporting Description Zero AEs were reported/observed during and at the end of treatment. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4
 
Arm/Group Title Open Label Single Arm, Drug Propanolol
Hide Arm/Group Description

all subjects will receive the experimental drug

propanolol: Participants will take 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed

All-Cause Mortality
Open Label Single Arm, Drug Propanolol
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Open Label Single Arm, Drug Propanolol
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open Label Single Arm, Drug Propanolol
Affected / at Risk (%)
Total   0/2 (0.00%) 
slow accrual was noted , mostly due to scheduling of surgery
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Zeina Nahleh
Organization: TTUHSC-EP
Phone: 9152155195
EMail: zeina.nahleh@ttuhsc.edu
Layout table for additonal information
Responsible Party: Zeina Nahleh, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT02596867     History of Changes
Other Study ID Numbers: E15123
First Submitted: September 2, 2015
First Posted: November 4, 2015
Results First Submitted: May 5, 2017
Results First Posted: February 1, 2018
Last Update Posted: March 1, 2018