A Phase II randomized study of perioperative beta-blocker vs placebo on gene expression in newly diagnosed breast cancer

Phase 2

Completed

• Conditions: Breast cancer; Cancer - Breast

• Registration Number: ACTRN12615000889550
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

Written, informed consent;
-Female subjects with histologically-confirmed breast cancer, who will undergo surgical excision at PMCC at least 7 days after enrollment;
-Age 18-80 years old;
-World Health Organization ECOG performance status 0 or 1;

Exclusion Criteria

-Women who are pregnant or breast feeding;

-Women with absolute or relative contraindications to Propranolol:
Sick sinus syndrome.
Sinus bradycardia (less than 60 beats/minute).
First, Second or third degree atrioventricular block.
Resting blood pressure less than 100/60mmHg.
Untreated phaeochromocytoma
Untreated thyroid disorder
Patients receiving dihydropyridine or non-dihydropyridine Calcium Channel Blocking agents (eg diltiazem, verapamil, nifedipine, amlodipine)
Severe peripheral vascular disease (intermittent claudication)
Patients receiving anti-arrhythmic agents (eg amiodarone, sotalol, digoxin)
Patients with renal impairment (defined as Creatinine greater than 0.15mmol/L)
Patients with liver impairment: AST or ALT or ALP > 2.5 x upper limit of normal range (ULN), bilirubin > 1.5 x ULN, ALP > 2.5.
Patients receiving Clonidine, Digoxin, Rizatriptan, Cimetidine, Hydralazine, Guanethidine or Ergotamine
Episodes of major depression

-Breast resection within 6 months of study entry;

-Women who have received neoadjuvant chemotherapy prior to the planned breast cancer resection;

-Women with histologically demonstrated ductal carcinoma in situ;

-Non-English speaking women;

-Women using regular (daily) pre-operative anti-inflammatory agents eg NSAIDs and aspirin >100mg/day;

-Women using regular anxiolytics (eg benzodiazepines), alpha-receptor adrenergic agonists (eg Clonidine);

-Use of selective or non-selective beta-adrenergic inhibitors in the last three months (examples include Propranolol, Metoprolol, Atenolol, Sotalol);

-Past history of stroke;

-Women with moderate or severe asthma, as defined by previous Intensive Care Unit admission or oral steroid-requiring asthma;

-Other medical conditions considered prohibitive by the treating physician (including frailty).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary tumour gene expression (quantitative level: i.e. mRNA concentration within the cell sample) for each of 20,000 genes at baseline and at surgical resection.<br>[Day of surgery procurement of tumour. Compare with biopsy (pre-treatment) sample where available.]