Breast Cancer Index (BCI) Registry

Running, not enrolling

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT04875351

Run by

Biotheranostics, Inc.

People needed

3465

Starts

2021-04-14

Expected to finish

2028-12-01

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patient has distant metastatic disease (M1).
• Patient was diagnosed with metaplastic breast cancer, carcinosarcoma, sarcoma, neuroendocrine carcinoma, adenoid cystic carcinoma, or phyllodes tumor.

Where it is running

• Southern Cancer Center, PC - Mobile Infirmary — Mobile, Alabama, United States
• Southern Cancer Center, PC - Providence Hospital — Mobile, Alabama, United States
• Southern Cancer Center, PC - Springhill Medical Center — Mobile, Alabama, United States
• Arizona Oncology Associates, PC - Glendale - Saguaro Cancer Center — Glendale, Arizona, United States
• Arizona Oncology Associates, PC - Goodyear — Goodyear, Arizona, United States
• Arizona Oncology Associates, PC - Phoenix - Biltmore Cancer Center — Phoenix, Arizona, United States
• Arizona Oncology Associates, PC - Phoenix - Deer Valley — Phoenix, Arizona, United States
• Arizona Oncology Associates, PC - Scottsdale — Scottsdale, Arizona, United States
• Arizona Oncology Associates, PC - East Valley Cancer Center — Tempe, Arizona, United States
• Sansum Clinic - Ridley-Tree Cancer Center — Santa Barbara, California, United States
• Sansum Clinic - Ridley-Tree Cancer Center (Solvang) — Solvang, California, United States
• Rocky Mountain Cancer Center - Aurora — Aurora, Colorado, United States
• Rocky Mountain Cancer Center - Boulder — Boulder, Colorado, United States
• Rocky Mountain Cancer Center - Centennial — Centennial, Colorado, United States
• Rocky Mountain Cancer Center - Colorado Springs — Colorado Springs, Colorado, United States
• Rocky Mountain Cancer Center - Denver Midtown — Denver, Colorado, United States
• Rocky Mountain Cancer Center - Denver — Denver, Colorado, United States
• Rocky Mountain Cancer Center - Swedish Medical Center — Englewood, Colorado, United States
• Rocky Mountain Cancer Centers - Lakewood — Lakewood, Colorado, United States
• Rocky Mountain Cancer Center - Littleton — Littleton, Colorado, United States
• Rocky Mountain Cancer Center - Lone Tree — Lone Tree, Colorado, United States
• Rocky Mountain Cancer Center - Longmont — Longmont, Colorado, United States
• Rocky Mountain Cancer Center - Pueblo — Pueblo, Colorado, United States
• Rocky Mountain Cancer Center - Thornton — Thornton, Colorado, United States
• Southern Cancer Center, P.C. - Daphne — Daphne, Alabama, United States

Full record on ClinicalTrials.gov

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