The EMPOwER Study Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: Tamoxifen

• Registration Number: NCT03211572
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers

Detailed Description

The clinical trial will be a prospective, two strata, non-blinded, single institution, Health Canada approved, Window of Opportunity trial with 2 weeks of pre-surgical endocrine therapy using either anastrozole or tamoxifen. Tissue from the initial biopsy and from surgery will be sent for Ki67 analysis using the NanoString® Assay.

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-05
• Study First Submitted QC: 2017-07-05
• Last Update Submitted: 2017-07-05
• Study First Posted: 2017-07-07
• Last Update Posted: 2017-07-07
• Study Start: 2017-08
• Primary Completion: 2018-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

• Any patient with histologically confirmed newly diagnosed operable ER+, Her2 negative invasive carcinoma on diagnostic core biopsy that has a radiographic size ≥ 1.5 cm
• Histology has to be ductal, lobular or mixed
• Surgery date planned in the next 2-6 weeks
• Negative pregnancy test if of child baring potential
• Post-menopausal status verified by FSH and Estradiol (with 6 months of amenorrhea)

Exclusion Criteria

• Previous treatment with endocrine therapy, chemotherapy or chest wall radiation within last 6 months
• Known metastatic or recurrent breast cancer.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endocrine Therapy	Tamoxifen	Anastrozole 1 mg (postmenopausal) or tamoxifen 20mg (premenopausal) are to be taken orally each evening and would be started exactly 2 weeks prior to their surgery.

Primary Outcome Measures

Name	Time	Method
Endocrine Therapy response	at one year	Introduction and validation of the use of NanoString® technology and a development of a custom gene codeset predictive of endocrine therapy response into the window setting as a more robust and reliable method of biomarker assessment as compared to Ki67.

Secondary Outcome Measures

Name	Time	Method
Biomarker Predictive value	at one year	Window of Opportunity clinical trial design as a means to evaluate the predictive value of potential biomarkers or biomarker-based tools.