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)

This study is not yet open for participant recruitment.

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Contacts and Locations

Verified July 2017 by Ottawa Hospital Research Institute

Sponsor:

Information provided by (Responsible Party):

Ottawa Hospital Research Institute

ClinicalTrials.gov Identifier:

NCT03211572

First received: July 5, 2017

Last updated: NA

Last verified: July 2017

History: No changes posted

Purpose

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

Condition	Intervention	Phase
Breast Cancer	Drug: Tamoxifen	Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Intervention 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: No masking Primary Purpose: Other
Official Title:	Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers: The EMPOwER Study

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Genes and Gene Therapy Hormones

Drug Information available for: Tamoxifen Tamoxifen citrate Anastrozole

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:

Endocrine Therapy response [ Time Frame: 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:

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


Estimated Enrollment:	82
Anticipated Study Start Date:	August 2017
Estimated Study Completion Date:	August 2018
Estimated Primary Completion Date:	August 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: Tamoxifen Participants will take endocrine therapy for 2 weeks prior to surgery. Other Name: Anastrozole

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211572

Contacts


Contact: Angel Arnaout, Dr	613-737-7700 ext 79071	anarnaout@toh.ca

Sponsors and Collaborators

Ottawa Hospital Research Institute

Investigators


Principal Investigator:	Angel Arnaout, Dr.	The Ottawa Hospital

More Information


Responsible Party:	Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:	NCT03211572 History of Changes
Other Study ID Numbers:	20170345-01h
Study First Received:	July 5, 2017
Last Updated:	July 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Ottawa Hospital Research Institute:


breast

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Hormones Anastrozole Tamoxifen Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal	Antineoplastic Agents Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 11, 2017

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