NCT02596867

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 .

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
9 months until next milestone

Results Posted

Study results publicly available

February 1, 2018

Completed
Last Updated

March 1, 2018

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

September 2, 2015

Results QC Date

May 5, 2017

Last Update Submit

January 31, 2018

Conditions

Breast Cancer

Keywords

B adrenergic pathwayB Blocker

Outcome Measures

Primary Outcomes (1)

  • Evaluate the Effect of the Beta Blocker Propranolol on Reducing the Tumor Proliferative Index Using Ki-67.

    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 Outcomes (1)

  • Assess the Safety, Toxicity and Adherence to Propranolol.

    3 weeks

Study Arms (1)

open label single arm, drug propanolol

EXPERIMENTAL

all subjects will receive the experimental drug

Drug: propanolol

Interventions

propanololDRUG

Participants will take 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed

open label single arm, drug propanolol

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University HSC

El Paso, Texas, 79905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Limitations and Caveats

slow accrual was noted , mostly due to scheduling of surgery

Results Point of Contact

Title
Zeina Nahleh
Organization
TTUHSC-EP
zeina.nahleh@ttuhsc.edu
9152155195

Study Officials

  • Zeina Nahleh, MD

    Texas Tech University Health Sciences Center, El Paso

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 2, 2015

First Posted

November 4, 2015

Study Start

September 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

March 1, 2018

Results First Posted

February 1, 2018

Record last verified: 2018-01

Locations

US(1)