Neoadjuvant Propanolol in Breast Cancer
This trial is active, not recruiting.
|Sponsor||Texas Tech University Health Sciences Center, El Paso|
|Start date||September 2015|
|End date||June 2016|
|Trial size||30 participants|
|Trial identifier||NCT02596867, E15123|
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 .
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
all subjects will receive the experimental drug
Evaluate the effect of the beta blocker propranolol on reducing the tumor proliferative index using Ki-67.
time frame: 1 year
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
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
|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.|
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