Status:
ACTIVE_NOT_RECRUITING
Breast Cancer Index (BCI) Registry
Lead Sponsor:
Biotheranostics, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief 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 adher...
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...
Eligibility Criteria
Inclusion
- 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
- Patient has distant metastatic disease (M1).
- Patient was diagnosed with metaplastic breast cancer, carcinosarcoma, sarcoma, neuroendocrine carcinoma, adenoid cystic carcinoma, or phyllodes tumor.
Key Trial Info
Start Date :
April 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2028
Estimated Enrollment :
3465 Patients enrolled
Trial Details
Trial ID
NCT04875351
Start Date
April 14 2021
End Date
December 1 2028
Last Update
September 19 2024
Active Locations (105)
Enter a location and click search to find clinical trials sorted by distance.
1
Southern Cancer Center, P.C. - Daphne
Daphne, Alabama, United States, 36526
2
Southern Cancer Center, PC - Mobile Infirmary
Mobile, Alabama, United States, 36607
3
Southern Cancer Center, PC - Providence Hospital
Mobile, Alabama, United States, 36608
4
Southern Cancer Center, PC - Springhill Medical Center
Mobile, Alabama, United States, 36608