Neoadjuvant Propanolol in Breast Cancer

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

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 .

Key facts

Study ID

NCT02596867

Run by

Texas Tech University Health Sciences Center, El Paso

People needed

2

Starts

2015-09-01

Expected to finish

2017-05-01

Last updated by the study team

2018-03-01

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Texas Tech University HSC — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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