The EMPOwER Study Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers (OTT 17-01)

Ottawa Hospital Research Institute

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Tamoxifen

Study type: Interventional

Funder types: Other

Identifiers

NCT03211572

20170345-01h

Details and patient eligibility

About

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

Full 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.

Enrollment: 82 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

Endocrine Therapy

Experimental group

Description:

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.

Treatment:

Drug: Tamoxifen