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

NCT03211572 | Unknown Phase 2

• 1 other identifier: 20170345-01h
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breast Cancer

Keywords

breast

Outcome Measures

Primary Outcomes (1)

• 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.

  at one year

Secondary Outcomes (1)

• Biomarker Predictive value

  at one year

Study Arms (1)

Endocrine Therapy

EXPERIMENTAL

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

Interventions

Tamoxifen DRUG

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

Also known as: Anastrozole

Endocrine Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Previous treatment with endocrine therapy, chemotherapy or chest wall radiation within last 6 months
• Known metastatic or recurrent breast cancer.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen; Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Angel Arnaout, Dr.

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angel Arnaout, Dr

CONTACT

613-737-7700; anarnaout@toh.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 7, 2017
• Study Start: August 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: July 7, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share