Breast Cancer Clinical Trial
— NPBCOfficial title:
Pilot "Window of Opportunity" Neoadjuvant Study of Propranolol in Breast Cancer
Verified date | January 2018 |
Source | Texas Tech University Health Sciences Center, El Paso |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 .
Status | Terminated |
Enrollment | 2 |
Est. completion date | May 1, 2017 |
Est. primary completion date | May 1, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Texas Tech University HSC | El Paso | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University Health Sciences Center, El Paso |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the Effect of the Beta Blocker Propranolol on Reducing the Tumor Proliferative Index Using Ki-67. | 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 | 3 weeks | |
Secondary | Assess the Safety, Toxicity and Adherence to Propranolol. | Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.(Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4) | 3 weeks |
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