Breast Cancer Index (BCI) Registry

January 18, 2024 updated by: Biotheranostics, Inc.
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The BCI Registry is designed as a large-scale data registry and biospecimen repository to evaluate the clinical outcome of hormone receptor positive (HR+) early-stage breast cancer patients completing primary adjuvant endocrine therapy and are considering extended endocrine treatment. The impact of BCI test results on extended endocrine therapy decision-making and clinical use patterns will be characterized. Extended endocrine therapy-specific medication adherence will be assessed annually. Primary tumor tissue will be collected for scientific research purposes including molecular profiling and for correlative studies. The sample size will consist of approximately 3,000 subjects across 30-50 sites in the United States.

The BCI registry will recruit patients with HR+ stage I to III breast cancer following an initial 4-7 years of adjuvant endocrine therapy that will have BCI testing performed as part of routine clinical care and meet the inclusion/exclusion criteria. After signing the informed consent form (ICF) during screening, physicians and patients will complete the pre-test Decision Impact Questionnaire. Upon ordering BCI by the treating physician, primary tumor tissue obtained from the patient during previous breast-conserving surgery or mastectomy will be requested by Biotheranostics to perform BCI testing at Biotheranostics' CLIA certified and CAP accredited clinical laboratory in San Diego, CA. Following BCI testing, the physician will share and discuss the BCI results with their patients and recommend to either stop or extend endocrine therapy for an additional 5 years. The impact of the BCI test results on extended endocrine therapy decision-making will be assessed using the post-test Decision Impact Questionnaire, which will be completed by both physicians and patients. In addition, medication adherence will be evaluated in patients that are recommended for or elect to continue treatment to complete 10 years of adjuvant endocrine therapy.

BCI reports both a prognostic and predictive result and has been shown to significantly stratify patients based on the risk of late distant recurrence as well as to predict the likelihood of benefit from endocrine therapy in multiple prospective-retrospective studies within randomized controlled trial cohorts. The BCI registry study will determine the long-term outcome and BCI test performance to add prospective validation for the prognostic and predictive capabilities of BCI. In this context, the impact of BCI test results on treatment decision-making and subsequently prescribed treatments will be characterized.

Analysis of BCI test performance with long-term outcome will be performed by Kaplan-Meier analysis with log-rank test to assess the statistical significance of the risk stratification by BCI risk groups. Cox proportional hazards regression will be used to derive the hazard ratios (HR) and the associated 95% confidence intervals for the comparison of BCI risk groups. Univariate and multivariate analysis adjusting for clinical factors such as age, tumor size, grade, and treatment background (adjuvant endocrine therapy and chemotherapy) will be conducted. Descriptive statistics will be used to evaluate the decision-impact and medication adherence scores of patients enrolled in the study.

Each participating site will maintain appropriate medical and research records for this trial, in compliance with Section 4.9 of the ICH E6 GCP, and regulatory and institutional requirements for the protection of confidentiality of subjects. As part of participating in a Biotheranostics-sponsored study, each site will permit authorized representatives of the sponsor and regulatory agencies to examine clinical records for the purposes of quality assurance reviews, audits and evaluation of the study progress. The clinical trial manager will be in regular contact with the site research leader to check on progress and address any queries that they may have. Sites may be suspended from participating in the registry in the event of serious and persistent non-compliance with the protocol and/or Good Clinical Practice. Any major problems identified will be reported to the Trial Management Team and if necessary, the relevant regulatory bodies.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Southern Cancer Center, P.C. - Daphne
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center, PC - Springhill Medical Center
      • Mobile, Alabama, United States, 36607
        • Southern Cancer Center, PC - Mobile Infirmary
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center, PC - Providence Hospital
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Arizona Oncology Associates, PC - Glendale - Saguaro Cancer Center
      • Goodyear, Arizona, United States, 85395
        • Arizona Oncology Associates, PC - Goodyear
      • Phoenix, Arizona, United States, 85016
        • Arizona Oncology Associates, PC - Phoenix - Biltmore Cancer Center
      • Phoenix, Arizona, United States, 85027
        • Arizona Oncology Associates, PC - Phoenix - Deer Valley
      • Scottsdale, Arizona, United States, 85258
        • Arizona Oncology Associates, PC - Scottsdale
      • Tempe, Arizona, United States, 85284
        • Arizona Oncology Associates, PC - East Valley Cancer Center
    • California
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic - Ridley-Tree Cancer Center
      • Solvang, California, United States, 93463
        • Sansum Clinic - Ridley-Tree Cancer Center (Solvang)
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Center - Aurora
      • Boulder, Colorado, United States, 80303
        • Rocky Mountain Cancer Center - Boulder
      • Centennial, Colorado, United States, 80112
        • Rocky Mountain Cancer Center - Centennial
      • Colorado Springs, Colorado, United States, 80907
        • Rocky Mountain Cancer Center - Colorado Springs
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Center - Denver
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center - Denver Midtown
      • Englewood, Colorado, United States, 80113
        • Rocky Mountain Cancer Center - Swedish Medical Center
      • Lakewood, Colorado, United States, 80228
        • Rocky Mountain Cancer Centers - Lakewood
      • Littleton, Colorado, United States, 80120
        • Rocky Mountain Cancer Center - Littleton
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Center - Lone Tree
      • Longmont, Colorado, United States, 80504
        • Rocky Mountain Cancer Center - Longmont
      • Pueblo, Colorado, United States, 81003
        • Rocky Mountain Cancer Center - Pueblo
      • Thornton, Colorado, United States, 80260
        • Rocky Mountain Cancer Center - Thornton
    • Florida
      • Palm Bay, Florida, United States, 32901
        • Cancer Care Centers of Brevard, Inc.
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Illinois Cancer Specialists - Arlington Heights
      • Chicago Ridge, Illinois, United States, 60415
        • Affiliated Oncologists, LLC
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists - Niles
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Maryland Oncology Hematology, P.A. - Bethesda
      • Brandywine, Maryland, United States, 20613
        • Maryland Oncology Hematology, P.A. - Brandywine
      • Clinton, Maryland, United States, 20735
        • Maryland Oncology Hematology, P.A. - Clinton
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology Hematology, P.A. - Columbia
      • Frederick, Maryland, United States, 21702
        • Maryland Oncology Hematology, P.A. - Frederick
      • Lanham, Maryland, United States, 20706
        • Maryland Oncology Hematology, P.A. - Lanham
      • Rockville, Maryland, United States, 20850
        • Maryland Oncology Hematology, P.A. - Rockville - Aquilino Cancer Center
      • Silver Spring, Maryland, United States, 20904
        • Maryland Oncology Hematology, P.A. - Silver Spring - White Oak Cancer Center
    • New York
      • Albany, New York, United States, 12206
        • New York Oncology Hematology, P.C. - Albany Cancer Center
      • Albany, New York, United States, 12208
        • New York Oncology Hematology, P.C. - Albany Medical Center
      • Binghamton, New York, United States, 13905
        • Broome Oncology, LLC - Binghamton
      • Clifton Park, New York, United States, 12065
        • New York Oncology Hematology, P.C. - Clifton Park Cancer Center
      • Johnson City, New York, United States, 13790
        • Broome Oncology, LLC - Johnson City
    • Pennsylvania
      • Bensalem, Pennsylvania, United States, 19020
        • Alliance Cancer Specialists, PC
      • Broomall, Pennsylvania, United States, 19008
        • Consultants In Medical Oncology and Hematology, P.C.
      • Horsham, Pennsylvania, United States, 19044
        • Alliance Cancer Specialists, PC
      • Langhorne, Pennsylvania, United States, 19047
        • Alliance Cancer Specialists, PC
      • Philadelphia, Pennsylvania, United States, 19115
        • Alliance Cancer Specialists, PC
      • Sellersville, Pennsylvania, United States, 18960
        • Alliance Cancer Specialists, PC
      • Wynnewood, Pennsylvania, United States, 19096
        • Alliance Cancer Specialists, PC
    • Texas
      • Abilene, Texas, United States, 79606
        • Texas Oncology - Abilene
      • Allen, Texas, United States, 75013
        • Texas Oncology - Allen
      • Amarillo, Texas, United States, 79106
        • Texas Oncology - Amarillo
      • Arlington, Texas, United States, 76012
        • Texas Oncology - DFWW
      • Arlington, Texas, United States, 76014
        • Texas Oncology - DFWW
      • Beaumont, Texas, United States, 77702
        • Texas Oncology - Beaumont Mamie Mcfaddin Ward Cancer Center
      • Beaumont, Texas, United States, 77701
        • Texas Oncology - Beaumont
      • Bedford, Texas, United States, 76022
        • Texas Oncology - DFWW
      • Carrollton, Texas, United States, 75010
        • Texas Oncology - Carrollton
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, United States, 75230
        • Texas Oncology - Medical City Dallas
      • Dallas, Texas, United States, 75231
        • Texas Oncology - Presbyterian Cancer Center Dallas
      • Dallas, Texas, United States, 75203
        • Texas Oncology - DFWW
      • Dallas, Texas, United States, 75237
        • Texas Oncology - DFWW
      • Denison, Texas, United States, 75020
        • Texas Oncology - Denison
      • Denton, Texas, United States, 76201
        • Texas Oncology - Denton
      • El Paso, Texas, United States, 79938
        • Texas Oncology - El Paso Cancer Treatment Center Joe Battle
      • El Paso, Texas, United States, 79902
        • Texas Oncology - El Paso Cancer Treatment Center Grandview
      • El Paso, Texas, United States, 79915
        • Texas Oncology - El Paso Cancer Treatment Center Gateway
      • Flower Mound, Texas, United States, 75028
        • Texas Oncology - Flower Mound
      • Grapevine, Texas, United States, 76051
        • Texas Oncology - DFWW
      • Harlingen, Texas, United States, 78550
        • Texas Oncology - Harlingen
      • Houston, Texas, United States, 77024
        • Texas Oncology - Memorial City
      • Houston, Texas, United States, 77070
        • Texas Oncology - Willowbrook
      • Longview, Texas, United States, 75601
        • Texas Oncology - Northeast Texas
      • McAllen, Texas, United States, 78503
        • Texas Oncology - McAllen
      • McKinney, Texas, United States, 75071
        • Texas Oncology - McKinney
      • Midland, Texas, United States, 79701
        • Texas Oncology - Midland
      • New Braunfels, Texas, United States, 78130
        • Texas Oncology - New Braunfels
      • Odessa, Texas, United States, 79761
        • Texas Oncology - Odessa
      • Palestine, Texas, United States, 75801
        • Texas Oncology - Northeast Texas
      • Paris, Texas, United States, 75460
        • Texas Oncology - Northeast Texas
      • Plano, Texas, United States, 75093
        • Texas Oncology - Plano West
      • San Antonio, Texas, United States, 78240
        • Texas Oncology - San Antonio
      • San Antonio, Texas, United States, 78217
        • Texas Oncology - San Antonio Northeast
      • San Antonio, Texas, United States, 78212
        • Texas Oncology - San Antonio Downtown
      • San Antonio, Texas, United States, 78258
        • Texas Oncology - San Antonio Stone Oak
      • Sugar Land, Texas, United States, 77479
        • Texas Oncology - Sugar Land
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology - The Woodlands
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Northeast Texas
      • Waco, Texas, United States, 76712
        • Texas Oncology - Austin
      • Waco, Texas, United States, 76712
        • Texas Oncology - Horizon Circle
      • Webster, Texas, United States, 77598
        • Texas Oncology - Deke Slayton Cancer Center
      • Weslaco, Texas, United States, 78596
        • Texas Oncology - Weslaco
      • Wichita Falls, Texas, United States, 76310
        • Texas Oncology - Wichita Falls
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Virginia Cancer Specialists, PC - Alexandria
      • Arlington, Virginia, United States, 22205
        • Virginia Cancer Specialists, PC - Arlington
      • Chesapeake, Virginia, United States, 23320
        • Virginia Oncology Associates
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC - Fairfax
      • Gainesville, Virginia, United States, 20155
        • Virginia Cancer Specialists, PC - Gainesville
      • Leesburg, Virginia, United States, 20176
        • Virginia Cancer Specialists, PC - Loudoun
      • Newport News, Virginia, United States, 23606
        • Virginia Oncology Associates
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Virginia Beach, Virginia, United States, 23456
        • Virginia Oncology Associates
      • Williamsburg, Virginia, United States, 23188
        • Virginia Oncology Associates
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will include patients with stage I-III HR+ breast cancer that have signed an informed consent. Patients seen within a physician practice participating in the registry are potential candidates after meeting eligibility criteria requirements.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit Testing
Female patients diagnosed with hormone receptor-positive (HR+), lymph node-negative (LN-) or lymph node-positive (LN+, with 1-3 positive nodes) early-stage invasive breast cancer, who are distant recurrence-free.
Diagnostic 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.
Other Names:
  • Breast Cancer Index (BCI) Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine BCI test performance by evaluating the long-term outcome of BCI risk groups over the follow-up period.
Time Frame: 5 Years
5 Years
To determine medication adherence in patients undergoing extended endocrine therapy.
Time Frame: 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.
5 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To prospectively assess the impact of BCI on extended endocrine therapy decision-making.
Time Frame: 5 Years
The impact of the BCI test results on extended endocrine therapy decision making will be measured using pre- and post-test Decision Impact Questionnaires, which will be completed by both physicians and patients.
5 Years
To correlate BCI results with molecular tumor profiles in early stage breast cancer.
Time Frame: 5 Years
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotheranostics, Inc.

Investigators

  • Principal Investigator: Joyce A O'Shaughnessy, MD, US Oncology Network
  • Study Director: Kai Treuner, PhD, Biotheranostics, Inc.
  • Study Director: Amanda KL Anderson, PhD, Biotheranostics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2021

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTX-BCI-016-PRT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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