Breast Cancer Index (BCI) Registry
1 other identifier
observational
3,465
1 country
105
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
Longer than P75 for all trials
105 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 14, 2021
CompletedFirst Submitted
Initial submission to the registry
April 26, 2021
CompletedFirst Posted
Study publicly available on registry
May 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
September 19, 2024
September 1, 2024
7.6 years
April 26, 2021
September 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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 Outcomes (2)
To prospectively assess the impact of BCI on extended endocrine therapy decision-making.
5 Years
To correlate BCI results with molecular tumor profiles in early stage breast cancer.
5 Years
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (105)
Southern Cancer Center, P.C. - Daphne
Daphne, Alabama, 36526, United States
Southern Cancer Center, PC - Mobile Infirmary
Mobile, Alabama, 36607, United States
Southern Cancer Center, PC - Providence Hospital
Mobile, Alabama, 36608, United States
Southern Cancer Center, PC - Springhill Medical Center
Mobile, Alabama, 36608, United States
Arizona Oncology Associates, PC - Glendale - Saguaro Cancer Center
Glendale, Arizona, 85308, United States
Arizona Oncology Associates, PC - Goodyear
Goodyear, Arizona, 85395, United States
Arizona Oncology Associates, PC - Phoenix - Biltmore Cancer Center
Phoenix, Arizona, 85016, United States
Arizona Oncology Associates, PC - Phoenix - Deer Valley
Phoenix, Arizona, 85027, United States
Arizona Oncology Associates, PC - Scottsdale
Scottsdale, Arizona, 85258, United States
Arizona Oncology Associates, PC - East Valley Cancer Center
Tempe, Arizona, 85284, United States
Sansum Clinic - Ridley-Tree Cancer Center
Santa Barbara, California, 93105, United States
Sansum Clinic - Ridley-Tree Cancer Center (Solvang)
Solvang, California, 93463, United States
Rocky Mountain Cancer Center - Aurora
Aurora, Colorado, 80012, United States
Rocky Mountain Cancer Center - Boulder
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Center - Centennial
Centennial, Colorado, 80112, United States
Rocky Mountain Cancer Center - Colorado Springs
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Center - Denver Midtown
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Center - Denver
Denver, Colorado, 80220, United States
Rocky Mountain Cancer Center - Swedish Medical Center
Englewood, Colorado, 80113, United States
Rocky Mountain Cancer Centers - Lakewood
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Center - Littleton
Littleton, Colorado, 80120, United States
Rocky Mountain Cancer Center - Lone Tree
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Center - Longmont
Longmont, Colorado, 80504, United States
Rocky Mountain Cancer Center - Pueblo
Pueblo, Colorado, 81003, United States
Rocky Mountain Cancer Center - Thornton
Thornton, Colorado, 80260, United States
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, 32901, United States
Illinois Cancer Specialists - Arlington Heights
Arlington Heights, Illinois, 60005, United States
Affiliated Oncologists, LLC
Chicago Ridge, Illinois, 60415, United States
Illinois Cancer Specialists - Niles
Niles, Illinois, 60714, United States
Maryland Oncology Hematology, P.A. - Bethesda
Bethesda, Maryland, 20817, United States
Maryland Oncology Hematology, P.A. - Brandywine
Brandywine, Maryland, 20613, United States
Maryland Oncology Hematology, P.A. - Clinton
Clinton, Maryland, 20735, United States
Maryland Oncology Hematology, P.A. - Columbia
Columbia, Maryland, 21044, United States
Maryland Oncology Hematology, P.A. - Frederick
Frederick, Maryland, 21702, United States
Maryland Oncology Hematology, P.A. - Lanham
Lanham, Maryland, 20706, United States
Maryland Oncology Hematology, P.A. - Rockville - Aquilino Cancer Center
Rockville, Maryland, 20850, United States
Maryland Oncology Hematology, P.A. - Silver Spring - White Oak Cancer Center
Silver Spring, Maryland, 20904, United States
New York Oncology Hematology, P.C. - Albany Cancer Center
Albany, New York, 12206, United States
New York Oncology Hematology, P.C. - Albany Medical Center
Albany, New York, 12208, United States
Broome Oncology, LLC - Binghamton
Binghamton, New York, 13905, United States
New York Oncology Hematology, P.C. - Clifton Park Cancer Center
Clifton Park, New York, 12065, United States
Broome Oncology, LLC - Johnson City
Johnson City, New York, 13790, United States
Alliance Cancer Specialists, PC
Bensalem, Pennsylvania, 19020, United States
Consultants In Medical Oncology and Hematology, P.C.
Broomall, Pennsylvania, 19008, United States
Alliance Cancer Specialists, PC
Horsham, Pennsylvania, 19044, United States
Alliance Cancer Specialists, PC
Langhorne, Pennsylvania, 19047, United States
Alliance Cancer Specialists, PC
Philadelphia, Pennsylvania, 19115, United States
Alliance Cancer Specialists, PC
Sellersville, Pennsylvania, 18960, United States
Alliance Cancer Specialists, PC
Wynnewood, Pennsylvania, 19096, United States
Texas Oncology - Abilene
Abilene, Texas, 79606, United States
Texas Oncology - Allen
Allen, Texas, 75013, United States
Texas Oncology - Amarillo
Amarillo, Texas, 79106, United States
Texas Oncology - DFWW
Arlington, Texas, 76012, United States
Texas Oncology - DFWW
Arlington, Texas, 76014, United States
Texas Oncology - Beaumont
Beaumont, Texas, 77701, United States
Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center
Beaumont, Texas, 77702, United States
Texas Oncology - DFWW
Bedford, Texas, 76022, United States
Texas Oncology - Carrollton
Carrollton, Texas, 75010, United States
Texas Oncology - DFWW
Dallas, Texas, 75203, United States
Texas Oncology - Medical City Dallas
Dallas, Texas, 75230, United States
Texas Oncology - Presbyterian Cancer Center Dallas
Dallas, Texas, 75231, United States
Texas Oncology - DFWW
Dallas, Texas, 75237, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology - Denison
Denison, Texas, 75020, United States
Texas Oncology - Denton
Denton, Texas, 76201, United States
Texas Oncology - El Paso Cancer Treatment Center Grandview
El Paso, Texas, 79902, United States
Texas Oncology - El Paso Cancer Treatment Center Gateway
El Paso, Texas, 79915, United States
Texas Oncology - El Paso Cancer Treatment Center Joe Battle
El Paso, Texas, 79938, United States
Texas Oncology - Flower Mound
Flower Mound, Texas, 75028, United States
Texas Oncology - DFWW
Grapevine, Texas, 76051, United States
Texas Oncology - Harlingen
Harlingen, Texas, 78550, United States
Texas Oncology - Memorial City
Houston, Texas, 77024, United States
Texas Oncology - Willowbrook
Houston, Texas, 77070, United States
Texas Oncology - Northeast Texas
Longview, Texas, 75601, United States
Texas Oncology - McAllen
McAllen, Texas, 78503, United States
Texas Oncology - McKinney
McKinney, Texas, 75071, United States
Texas Oncology - Midland
Midland, Texas, 79701, United States
Texas Oncology - New Braunfels
New Braunfels, Texas, 78130, United States
Texas Oncology - Odessa
Odessa, Texas, 79761, United States
Texas Oncology - Northeast Texas
Palestine, Texas, 75801, United States
Texas Oncology - Northeast Texas
Paris, Texas, 75460, United States
Texas Oncology - Plano West
Plano, Texas, 75093, United States
Texas Oncology - San Antonio Downtown
San Antonio, Texas, 78212, United States
Texas Oncology - San Antonio Northeast
San Antonio, Texas, 78217, United States
Texas Oncology - San Antonio
San Antonio, Texas, 78240, United States
Texas Oncology - San Antonio Stone Oak
San Antonio, Texas, 78258, United States
Texas Oncology - Sugar Land
Sugar Land, Texas, 77479, United States
Texas Oncology - The Woodlands
The Woodlands, Texas, 77380, United States
Texas Oncology - Northeast Texas
Tyler, Texas, 75702, United States
Texas Oncology - Austin
Waco, Texas, 76712, United States
Texas Oncology - Horizon Circle
Waco, Texas, 76712, United States
Texas Oncology - Deke Slayton Cancer Center
Webster, Texas, 77598, United States
Texas Oncology - Weslaco
Weslaco, Texas, 78596, United States
Texas Oncology - Wichita Falls
Wichita Falls, Texas, 76310, United States
Virginia Cancer Specialists, PC - Alexandria
Alexandria, Virginia, 22304, United States
Virginia Cancer Specialists, PC - Arlington
Arlington, Virginia, 22205, United States
Virginia Oncology Associates
Chesapeake, Virginia, 23320, United States
Virginia Cancer Specialists, PC - Fairfax
Fairfax, Virginia, 22031, United States
Virginia Cancer Specialists, PC - Gainesville
Gainesville, Virginia, 20155, United States
Virginia Cancer Specialists, PC - Loudoun
Leesburg, Virginia, 20176, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Oncology Associates
Virginia Beach, Virginia, 23456, United States
Virginia Oncology Associates
Williamsburg, Virginia, 23188, United States
Shenandoah Oncology, P.C.
Winchester, Virginia, 22601, United States
Related Publications (5)
Noordhoek I, Treuner K, Putter H, Zhang Y, Wong J, Meershoek-Klein Kranenbarg E, Duijm-de Carpentier M, van de Velde CJH, Schnabel CA, Liefers GJ. Breast Cancer Index Predicts Extended Endocrine Benefit to Individualize Selection of Patients with HR+ Early-stage Breast Cancer for 10 Years of Endocrine Therapy. Clin Cancer Res. 2021 Jan 1;27(1):311-319. doi: 10.1158/1078-0432.CCR-20-2737. Epub 2020 Oct 27.
PMID: 33109739BACKGROUNDBartlett JMS, Sgroi DC, Treuner K, Zhang Y, Ahmed I, Piper T, Salunga R, Brachtel EF, Pirrie SJ, Schnabel CA, Rea DW. Breast Cancer Index and prediction of benefit from extended endocrine therapy in breast cancer patients treated in the Adjuvant Tamoxifen-To Offer More? (aTTom) trial. Ann Oncol. 2019 Nov 1;30(11):1776-1783. doi: 10.1093/annonc/mdz289.
PMID: 31504126BACKGROUNDZhang Y, Schnabel CA, Schroeder BE, Jerevall PL, Jankowitz RC, Fornander T, Stal O, Brufsky AM, Sgroi D, Erlander MG. Breast cancer index identifies early-stage estrogen receptor-positive breast cancer patients at risk for early- and late-distant recurrence. Clin Cancer Res. 2013 Aug 1;19(15):4196-205. doi: 10.1158/1078-0432.CCR-13-0804. Epub 2013 Jun 11.
PMID: 23757354BACKGROUNDSgroi DC, Sestak I, Cuzick J, Zhang Y, Schnabel CA, Schroeder B, Erlander MG, Dunbier A, Sidhu K, Lopez-Knowles E, Goss PE, Dowsett M. Prediction of late distant recurrence in patients with oestrogen-receptor-positive breast cancer: a prospective comparison of the breast-cancer index (BCI) assay, 21-gene recurrence score, and IHC4 in the TransATAC study population. Lancet Oncol. 2013 Oct;14(11):1067-1076. doi: 10.1016/S1470-2045(13)70387-5. Epub 2013 Sep 12.
PMID: 24035531BACKGROUNDSgroi DC, Carney E, Zarrella E, Steffel L, Binns SN, Finkelstein DM, Szymonifka J, Bhan AK, Shepherd LE, Zhang Y, Schnabel CA, Erlander MG, Ingle JN, Porter P, Muss HB, Pritchard KI, Tu D, Rimm DL, Goss PE. Prediction of late disease recurrence and extended adjuvant letrozole benefit by the HOXB13/IL17BR biomarker. J Natl Cancer Inst. 2013 Jul 17;105(14):1036-42. doi: 10.1093/jnci/djt146. Epub 2013 Jun 28.
PMID: 23812955BACKGROUND
Biospecimen
Tumor Tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2021
First Posted
May 6, 2021
Study Start
April 14, 2021
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share