Neoadjuvant Propanolol in Breast Cancer

- 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.

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