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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
Sponsor:
Information provided by (Responsible Party):
Zeina Nahleh, Texas Tech University Health Sciences Center, El Paso

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 .

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: propanolol Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: open label single arm, drug propanolol
all subjects will receive the experimental drug
Drug: propanolol
Participants will take 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Texas
Texas Tech University HSC
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
Investigators
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Principal Investigator: Zeina Nahleh, MD Texas Tech University Health Sciences Center, El Paso
  Study Documents (Full-Text)

Documents provided by Zeina Nahleh, Texas Tech University Health Sciences Center, El Paso:

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Responsible Party: Zeina Nahleh, Professor, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT02596867     History of Changes
Other Study ID Numbers: E15123
First Posted: November 4, 2015    Key Record Dates
Results First Posted: February 1, 2018
Last Update Posted: March 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: if the study is completed, yes

Keywords provided by Zeina Nahleh, Texas Tech University Health Sciences Center, El Paso:
B adrenergic pathway
B Blocker

Additional relevant MeSH terms:
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Propranolol
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents