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

NCT ID: NCT03211572

Last Updated: 2017-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2018-08-31

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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Endocrine Therapy

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.

Group Type EXPERIMENTAL

Tamoxifen

Intervention Type DRUG

Participants will take endocrine therapy for 2 weeks prior to surgery.

Interventions

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Tamoxifen

Participants will take endocrine therapy for 2 weeks prior to surgery.

Intervention Type DRUG

Other Intervention Names

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Anastrozole

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angel Arnaout, Dr.

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Central Contacts

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Angel Arnaout, Dr

Role: CONTACT

613-737-7700 ext. 79071

Other Identifiers

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20170345-01h

Identifier Type: -

Identifier Source: org_study_id

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