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

Sponsor
Ottawa Hospital Research Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT03211572
Collaborator
(none)
82
Enrollment
1
Arm
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
82 participants
Allocation:
N/A
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.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)
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
Anticipated Study Start Date :
Aug 1, 2017
Anticipated Primary Completion Date :
Aug 1, 2018
Anticipated Study Completion Date :
Aug 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Anastrozole

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ottawa Hospital Research Institute

    Investigators

    • Principal Investigator: Angel Arnaout, Dr., The Ottawa Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ottawa Hospital Research Institute
    ClinicalTrials.gov Identifier:
    NCT03211572
    Other Study ID Numbers:
    • 20170345-01h
    First Posted:
    Jul 7, 2017
    Last Update Posted:
    Jul 7, 2017
    Last Verified:
    Jul 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    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
    Tamoxifen
    Anastrozole

    Study Results

    No Results Posted as of Jul 7, 2017