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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03211572

Acronym

OTT 17-01

Enrollment

Registered

2017-07-07

Start date

2017-08-31

Completion date

2018-08-31

Last updated

2017-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast

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.

Interventions

DRUGTamoxifen

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

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.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Contacts

Primary ContactAngel Arnaout, Dr

anarnaout@toh.ca613-737-7700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026