Pilot "Window of Opportunity" Neoadjuvant Study of Propranolol in Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- propanolol
- Conditions
- Breast Cancer
- Sponsor
- Texas Tech University Health Sciences Center, El Paso
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Evaluate the Effect of the Beta Blocker Propranolol on Reducing the Tumor Proliferative Index Using Ki-67.
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief 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 .
Detailed Description
* 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.
Investigators
Zeina Nahleh
Professor
Texas Tech University Health Sciences Center, El Paso
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
Exclusion Criteria
- Not provided
Arms & Interventions
open label single arm, drug propanolol
all subjects will receive the experimental drug
Intervention: propanolol
Outcomes
Primary Outcomes
Evaluate the Effect of the Beta Blocker Propranolol on Reducing the Tumor Proliferative Index Using Ki-67.
Time Frame: 3 weeks
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
Secondary Outcomes
- Assess the Safety, Toxicity and Adherence to Propranolol.(3 weeks)