Trial Outcomes & Findings for Study of Propranolol in Newly Diagnosed Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy (NCT NCT01847001)

NCT ID: NCT01847001

Last Updated: 2021-09-10

Results Overview

Propranolol adherence was documented biweekly by pill counts and drug diary checks.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: Approximately 6 months
• Results posted on: 2021-09-10

Participant Flow

Participant milestones

Measure	Propranolol + Neoadjuvant Chemotherapy Subjects will receive 2 types of chemotherapy regimens plus propranolol treatment. * Regimen I, involves paclitaxel (may be substituted with nab-paclitaxel; maybe given with premedication), and * Regimen II involves doxorubicin (maybe given with anti-nausea therapy) and cyclophosphamide (maybe given with Pegfilgrastim). * If your tumor is HER2 positive, you will also receive trastuzumab and pertuzumab. After you complete all chemotherapy plus propranolol treatment, you will then have surgery to remove the breast tumor. DOT imaging will be done at 4 additional time points, including beo. Propranolol: Propranolol starting dose is 20mg b.i.d.; propranolol dose is up-titrated to 40mg b.i.d. to 80 mg daily with chemotherapy depending on tolerability. Tolerability is assessed every 2 weeks.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Propranolol in Newly Diagnosed Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy

Baseline characteristics by cohort

Measure	Propranolol + Neoadjuvant Chemotherapy n=10 Participants Subjects will receive 2 types of chemotherapy regimens plus propranolol treatment. * Regimen I, involves paclitaxel (may be substituted with nab-paclitaxel; maybe given with premedication), and * Regimen II involves doxorubicin (maybe given with anti-nausea therapy) and cyclophosphamide (maybe given with Pegfilgrastim). * If your tumor is HER2 positive, you will also receive trastuzumab and pertuzumab. After you complete all chemotherapy plus propranolol treatment, you will then have surgery to remove the breast tumor. DOT imaging will be done at 4 additional time points, including beo. Propranolol: Propranolol starting dose is 20mg b.i.d.; propranolol dose is up-titrated to 40mg b.i.d. to 80 mg daily with chemotherapy depending on tolerability. Tolerability is assessed every 2 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Systolic Blood Pressure Measured	121.7 mmHg n=5 Participants
Average Heart Rate (HR)	76.8 bpm n=5 Participants

PRIMARY outcome

Timeframe: Approximately 6 months

Propranolol adherence was documented biweekly by pill counts and drug diary checks.

Outcome measures

Measure

Propranolol + Neoadjuvant Chemotherapy n=10 Participants Subjects will receive 2 types of chemotherapy regimens plus propranolol treatment. * Regimen I, involves paclitaxel (may be substituted with nab-paclitaxel; maybe given with premedication), and * Regimen II involves doxorubicin (maybe given with anti-nausea therapy) and cyclophosphamide (maybe given with Pegfilgrastim). * If your tumor is HER2 positive, you will also receive trastuzumab and pertuzumab. After you complete all chemotherapy plus propranolol treatment, you will then have surgery to remove the breast tumor. DOT imaging will be done at 4 additional time points, including beo. Propranolol: Propranolol starting dose is 20mg b.i.d.; propranolol dose is up-titrated to 40mg b.i.d. to 80 mg daily with chemotherapy depending on tolerability. Tolerability is assessed every 2 weeks.

Mean Adherence to Propranolol

96 Percentage of propanolol adherence Interval 89.0 to 100.0

PRIMARY outcome

Timeframe: Approximately 6 months

The target Propranolol dosing was 80mg ER daily.

Outcome measures

Measure

Propranolol + Neoadjuvant Chemotherapy n=10 Participants Subjects will receive 2 types of chemotherapy regimens plus propranolol treatment. * Regimen I, involves paclitaxel (may be substituted with nab-paclitaxel; maybe given with premedication), and * Regimen II involves doxorubicin (maybe given with anti-nausea therapy) and cyclophosphamide (maybe given with Pegfilgrastim). * If your tumor is HER2 positive, you will also receive trastuzumab and pertuzumab. After you complete all chemotherapy plus propranolol treatment, you will then have surgery to remove the breast tumor. DOT imaging will be done at 4 additional time points, including beo. Propranolol: Propranolol starting dose is 20mg b.i.d.; propranolol dose is up-titrated to 40mg b.i.d. to 80 mg daily with chemotherapy depending on tolerability. Tolerability is assessed every 2 weeks.

Total Number of Participants Who Reached The Target Propranolol Dosing

9 Participants

SECONDARY outcome

Timeframe: Approximately 6 months

Response was confirmed with pathology.

Outcome measures

Measure

Propranolol + Neoadjuvant Chemotherapy n=10 Participants Subjects will receive 2 types of chemotherapy regimens plus propranolol treatment. * Regimen I, involves paclitaxel (may be substituted with nab-paclitaxel; maybe given with premedication), and * Regimen II involves doxorubicin (maybe given with anti-nausea therapy) and cyclophosphamide (maybe given with Pegfilgrastim). * If your tumor is HER2 positive, you will also receive trastuzumab and pertuzumab. After you complete all chemotherapy plus propranolol treatment, you will then have surgery to remove the breast tumor. DOT imaging will be done at 4 additional time points, including beo. Propranolol: Propranolol starting dose is 20mg b.i.d.; propranolol dose is up-titrated to 40mg b.i.d. to 80 mg daily with chemotherapy depending on tolerability. Tolerability is assessed every 2 weeks.

Number of Patients With Pathologic Complete Response

1 Participants

Adverse Events

Propranolol + Neoadjuvant Chemotherapy

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure

Propranolol + Neoadjuvant Chemotherapy n=10 participants at risk Subjects will receive 2 types of chemotherapy regimens plus propranolol treatment. * Regimen I, involves paclitaxel (may be substituted with nab-paclitaxel; maybe given with premedication), and * Regimen II involves doxorubicin (maybe given with anti-nausea therapy) and cyclophosphamide (maybe given with Pegfilgrastim). * If your tumor is HER2 positive, you will also receive trastuzumab and pertuzumab. After you complete all chemotherapy plus propranolol treatment, you will then have surgery to remove the breast tumor. DOT imaging will be done at 4 additional time points, including beo. Propranolol: Propranolol starting dose is 20mg b.i.d.; propranolol dose is up-titrated to 40mg b.i.d. to 80 mg daily with chemotherapy depending on tolerability. Tolerability is assessed every 2 weeks.

Gastrointestinal disorders Colitis

10.0% 1/10 • Number of events 1 • 3 years Adverse events will be collected/analyzed and reported by December 2020.

Other adverse events

Measure	Propranolol + Neoadjuvant Chemotherapy n=10 participants at risk Subjects will receive 2 types of chemotherapy regimens plus propranolol treatment. * Regimen I, involves paclitaxel (may be substituted with nab-paclitaxel; maybe given with premedication), and * Regimen II involves doxorubicin (maybe given with anti-nausea therapy) and cyclophosphamide (maybe given with Pegfilgrastim). * If your tumor is HER2 positive, you will also receive trastuzumab and pertuzumab. After you complete all chemotherapy plus propranolol treatment, you will then have surgery to remove the breast tumor. DOT imaging will be done at 4 additional time points, including beo. Propranolol: Propranolol starting dose is 20mg b.i.d.; propranolol dose is up-titrated to 40mg b.i.d. to 80 mg daily with chemotherapy depending on tolerability. Tolerability is assessed every 2 weeks.
General disorders Fatigue	20.0% 2/10 • Number of events 2 • 3 years Adverse events will be collected/analyzed and reported by December 2020.
Cardiac disorders QTc prolongation	20.0% 2/10 • Number of events 2 • 3 years Adverse events will be collected/analyzed and reported by December 2020.
Blood and lymphatic system disorders Neutropenia	10.0% 1/10 • Number of events 1 • 3 years Adverse events will be collected/analyzed and reported by December 2020.
Infections and infestations Central line infection	10.0% 1/10 • Number of events 1 • 3 years Adverse events will be collected/analyzed and reported by December 2020.
General disorders Infusion Reaction	10.0% 1/10 • Number of events 1 • 3 years Adverse events will be collected/analyzed and reported by December 2020.

Additional Information

Dr. Kevin Kalinsky

Columbia University Medical Center

Phone: 212-305-1925

Email: cancerclinicaltrials@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place