Neoadjuvant Propanolol in Breast Cancer (NPBC)
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|ClinicalTrials.gov Identifier: NCT02596867|
Recruitment Status : Terminated (poor accrual)
First Posted : November 4, 2015
Results First Posted : February 1, 2018
Last Update Posted : March 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: propanolol||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot "Window of Opportunity" Neoadjuvant Study of Propranolol in Breast Cancer|
|Actual Study Start Date :||September 1, 2015|
|Actual Primary Completion Date :||May 1, 2017|
|Actual Study Completion Date :||May 1, 2017|
Experimental: open label single arm, drug propanolol
all subjects will receive the experimental drug
Participants will take 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed
- 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
- Assess the Safety, Toxicity and Adherence to Propranolol. [ Time Frame: 3 weeks ]Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.(Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596867
|United States, Texas|
|Texas Tech University HSC|
|El Paso, Texas, United States, 79905|
|Principal Investigator:||Zeina Nahleh, MD||Texas Tech University Health Sciences Center, El Paso|