Neoadjuvant Propanolol in Breast Cancer (NPBC)

January 31, 2018 updated by: Zeina Nahleh, Texas Tech University Health Sciences Center, El Paso

Pilot "Window of Opportunity" Neoadjuvant Study of Propranolol in Breast Cancer

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 .

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • El Paso, Texas, United States, 79905
        • Texas Tech University HSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Tech University Health Sciences Center, El Paso

Investigators

  • Principal Investigator: Zeina Nahleh, MD, Texas Tech University Health Sciences Center, El Paso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

September 2, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (Estimate)

November 4, 2015

Study Record Updates

Last Update Posted (Actual)

March 1, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E15123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

if the study is completed, yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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