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Breast Cancer Index (BCI) Registry

NCT04875351 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 3465

Last updated 2024-09-19

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Biotheranostics, Inc.

    lead INDUSTRY

Principal Investigators

  • Joyce A O'Shaughnessy, MD · US Oncology Network

  • Kai Treuner, PhD · Biotheranostics, Inc.

  • Amanda KL Anderson, PhD · Biotheranostics, Inc.

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04875351 on ClinicalTrials.gov