Neoadjuvant Propanolol in Breast Cancer

• Status: Terminated
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: Female

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 .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Texas Tech University Health Sciences Center, El Paso
• Treatments: Propranolol

Criteria

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