Neoadjuvant Propanolol in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: propanolol
Intervention description: Participants will take 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed
Intervention MeSH terms: Propranolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: B adrenergic pathway; B Blocker

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 .
    

Eligibility 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