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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)

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tamoxifen
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring breast

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Endocrine Therapy

    Arm 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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Biomarker Predictive value
    Window of Opportunity clinical trial design as a means to evaluate the predictive value of potential biomarkers or biomarker-based tools.

    Full Information

    First Posted
    July 5, 2017
    Last Updated
    July 5, 2017
    Sponsor
    Ottawa Hospital Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03211572
    Brief Title
    The EMPOwER Study Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers
    Acronym
    OTT 17-01
    Official Title
    Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers: The EMPOwER Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2017 (Anticipated)
    Primary Completion Date
    August 2018 (Anticipated)
    Study Completion Date
    August 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ottawa Hospital Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    breast

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    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)
    Allocation
    N/A
    Enrollment
    82 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Endocrine Therapy
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Tamoxifen
    Other Intervention Name(s)
    Anastrozole
    Intervention Description
    Participants will take endocrine therapy for 2 weeks prior to surgery.
    Primary Outcome Measure Information:
    Title
    Endocrine Therapy response
    Description
    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.
    Time Frame
    at one year
    Secondary Outcome Measure Information:
    Title
    Biomarker Predictive value
    Description
    Window of Opportunity clinical trial design as a means to evaluate the predictive value of potential biomarkers or biomarker-based tools.
    Time Frame
    at one year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Angel Arnaout, Dr
    Phone
    613-737-7700
    Ext
    79071
    Email
    anarnaout@toh.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Angel Arnaout, Dr.
    Organizational Affiliation
    The Ottawa Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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