Ireland
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Active, not recruiting Observational

Breast Cancer Index (BCI) Registry

NCT04875351 · tracked via the Priya Life Science USA tracker
Sponsor
Biotheranostics, Inc
Phase
Observational
Started
2021-04-14
Last updated
2024-09-19

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit Test

Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit Test: The BCI test provides a quantitative estimate of the risk for both late (post-5 years from diagnosis) distant recurrence and of the cumulative distant recurrence risk over 10 years (0-10y) in patients treated with adjuvant endocrine therapy (LN- patients) or adjuvant chemoendocrine therapy (LN+ patients), and prediction of the likelihood of benefit from extended (\>5 year) endocrine therapy.

Study summary

The purpose of the Breast Cancer Index (BCI) Registry study is to conduct a large scale, population-based prospective registry to evaluate long-term clinical outcome, clinical impact, medication adherence and quality of life in hormone receptor positive (HR+) early-stage breast cancer patients receiving BCI testing as part of routine clinical care to inform extended endocrine therapy.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Early stage (I, II or III) female breast cancer patients, who have completed 4-7 years of primary adjuvant endocrine therapy * Patient was diagnosed with invasive breast carcinoma (ductal, lobular, or mixed ductal/lobular). * The primary tumor was hormone receptor positive (HR+), i.e. estrogen receptor-positive and/or progesterone receptor-positive. * The primary tumor was HER2 negative or positive and node-negative or node-positive with 1-3 positive lymph nodes. * Subject has pre-treatment breast tumor tissue \[formalin fixed and paraffin embedded (FFPE)\] from a previous breast-conserving surgery, mastectomy or core needle biopsy available for testing by the Sponsor. Exclusion Criteria: * Patient has distant metastatic disease (M1). * Patient was diagnosed with metaplastic breast cancer, carcinosarcoma, sarcoma, neuroendocrine carcinoma, adenoid cystic carcinoma, or phyllodes tumor.

Primary outcome measure(s)

  • To determine BCI test performance by evaluating the long-term outcome of BCI risk groups over the follow-up period. — 5 Years
  • To determine medication adherence in patients undergoing extended endocrine therapy. — 5 Years
    Patients will be asked to complete a Medication Adherence Questionnaire during routine follow-up visits. Medication adherence scores over time will be evaluated in patients that are recommended for or elect to continue treatment to complete 10 years of adjuvant endocrine therapy.

Trial sites (105)

FacilityCityRegionStatus
Southern Cancer Center, P.C. - Daphne Daphne Alabama
Southern Cancer Center, PC - Mobile Infirmary Mobile Alabama
Southern Cancer Center, PC - Providence Hospital Mobile Alabama
Southern Cancer Center, PC - Springhill Medical Center Mobile Alabama
Arizona Oncology Associates, PC - Glendale - Saguaro Cancer Center Glendale Arizona
Arizona Oncology Associates, PC - Goodyear Goodyear Arizona
Arizona Oncology Associates, PC - Phoenix - Biltmore Cancer Center Phoenix Arizona
Arizona Oncology Associates, PC - Phoenix - Deer Valley Phoenix Arizona
Arizona Oncology Associates, PC - Scottsdale Scottsdale Arizona
Arizona Oncology Associates, PC - East Valley Cancer Center Tempe Arizona
Sansum Clinic - Ridley-Tree Cancer Center Santa Barbara California
Sansum Clinic - Ridley-Tree Cancer Center (Solvang) Solvang California
Rocky Mountain Cancer Center - Aurora Aurora Colorado
Rocky Mountain Cancer Center - Boulder Boulder Colorado
Rocky Mountain Cancer Center - Centennial Centennial Colorado
Rocky Mountain Cancer Center - Colorado Springs Colorado Springs Colorado
Rocky Mountain Cancer Center - Denver Midtown Denver Colorado
Rocky Mountain Cancer Center - Denver Denver Colorado
Rocky Mountain Cancer Center - Swedish Medical Center Englewood Colorado
Rocky Mountain Cancer Centers - Lakewood Lakewood Colorado
Rocky Mountain Cancer Center - Littleton Littleton Colorado
Rocky Mountain Cancer Center - Lone Tree Lone Tree Colorado
Rocky Mountain Cancer Center - Longmont Longmont Colorado
Rocky Mountain Cancer Center - Pueblo Pueblo Colorado
Rocky Mountain Cancer Center - Thornton Thornton Colorado
Cancer Care Centers of Brevard, Inc. Palm Bay Florida
Illinois Cancer Specialists - Arlington Heights Arlington Heights Illinois
Affiliated Oncologists, LLC Chicago Ridge Illinois
Illinois Cancer Specialists - Niles Niles Illinois
Maryland Oncology Hematology, P.A. - Bethesda Bethesda Maryland
Maryland Oncology Hematology, P.A. - Brandywine Brandywine Maryland
Maryland Oncology Hematology, P.A. - Clinton Clinton Maryland
Maryland Oncology Hematology, P.A. - Columbia Columbia Maryland
Maryland Oncology Hematology, P.A. - Frederick Frederick Maryland
Maryland Oncology Hematology, P.A. - Lanham Lanham Maryland
Maryland Oncology Hematology, P.A. - Rockville - Aquilino Cancer Center Rockville Maryland
Maryland Oncology Hematology, P.A. - Silver Spring - White Oak Cancer Center Silver Spring Maryland
New York Oncology Hematology, P.C. - Albany Cancer Center Albany New York
New York Oncology Hematology, P.C. - Albany Medical Center Albany New York
Broome Oncology, LLC - Binghamton Binghamton New York

+ 65 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04875351 on ClinicalTrials.gov ↗ ← All trials in the USA