Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment propanolol
Phase phase 2
Sponsor Texas Tech University Health Sciences Center, El Paso
Start date September 2015
End date June 2017
Trial size 30 participants
Trial identifier NCT02596867, E15123

Summary

This trial is a Phase II study using the "window-of-opportunity" design in which the treatment-free window between breast cancer diagnosis and surgical tumor resection is used to study the biological effects of the beta blocker propranolol .

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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

Primary Outcomes

Measure
Evaluate the effect of the beta blocker propranolol on reducing the tumor proliferative index using Ki-67.
time frame: 1 year

Secondary Outcomes

Measure
Assess the safety, toxicity and adherence to propranolol. (Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4)
time frame: 1 year

Eligibility Criteria

Female participants from 18 years up to 65 years old.

Inclusion Criteria: - Ages 18- 65 - diagnosis of stage I-III breast cancer , confirmed by a core biopsy - Planning to undergo definitive surgery including mastectomy or breast conserving surgery - Systolic blood pressure must be >100 mmHg but no more than 140 mmHg and/or diastolic > 60 mmHg and no more than 95 mmHg. - normal baseline EKG Exclusion criteria: - Pregnancy; potential subjects of female bearing age will have to complete a pregnancy test during screening to ensure that they are not pregnant. Potential patients who are post-menopausal must have confirmed one year without menstrual cycle. - Free of major medical illnesses including: - Uncontrolled Diabetes (HbA1c of ≤ 8 if previously tested) - Uncontrolled hypertension: BP >systolic 140/ diastolic > 95 - Cardiac diseases (history of cardiac valve disease, coronary artery disease, congestive heart failure, A-V block, peripheral vascular disease, any cardiac arrhythmia/bradycardia) with the exception of the diagnosed cancer. - Histories of asthma, bronchospastic disease, or obstructive pulmonary disease - Previously diagnosed thyrotoxicosis - Severe allergic reactions to medications which are included in the beta blocker family - Previously or currently treated with a beta adrenergic receptor antagonist - Patients with locally advanced or inflammatory breast cancer not amenable to surgical resection - Patients taking any of the following medications will be excluded: - Drugs that are categorized as digitalis glycosides, beta-blockers and calcium channel blockers, ACE inhibitors and alpha blockers - Amiodarone - Cimetidine - Ciprofloxacin - Delavudin - Dobutamine - Ethanol - Fluconazole - Fluoxetine - Fluvoxamine - Haloperidol - Imipramine - Isoniazid - Isoproterenol - Luvoxamine - Paroxetine - Phenytoin - Phenobarbital. - Propafenone. - Quinidine - Reserpine - Rifampin - Ritonavir - Rizatriptan. - Tenioposide - Theophylline - Thyroxine - Tolbutamide. - Warfarin - Zileuton - Zolmitriptan

Additional Information

Official title Pilot "Window of Opportunity" Neoadjuvant Study of Propranolol in Breast Cancer
Description - Patients will be recruited from the Garbar Breast Care Center and University Medical Center following diagnosis of invasive breast cancer by breast biopsy. - The sympatholytic nonselective beta blocker propranolol will be administered to all participants in a non-randomized manner at an equal dose of 1.5 mg/kg/day. - Following surgical resection of the tumor , the primary endpoint of this study is quantified by comparing the proliferative index of the tumor before propranolol administration (quantified using the initial tumor biopsy) and after 3 weeks of propranolol (quantified using the surgically resected tumor). - Additional molecular analyses and evaluation of safety and toxicity will also be performed to better understand the effects of this treatment on breast cancers and patient adherence to the drug.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Texas Tech University Health Sciences Center, El Paso.