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

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

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Tamoxifen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endocrine Therapy<br>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. | Drug: Tamoxifen<br>* Participants will take endocrine therapy for 2 weeks prior to surgery.<br>* Other names: Anastrozole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endocrine Therapy response | 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. | at one year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast