Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
3465 participants
OBSERVATIONAL
2021-04-14
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessment of the Decision-making Impact of the Breast Cancer Index in Recommending Extended Adjuvant Endocrine Therapy for Patients With Early Stage ER-positive Breast Cancer
NCT02057029
Breast Cancer Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer
NCT00666731
Magnetic Resonance Imaging in Patients With Breast Cancer
NCT00610181
Screening in Myocardial Perfusion Patients
NCT00943241
Biospecimen and Medical Data Collection and Tumor Biopsy in Creating Research Tissue Registry in Patients With Inflammatory or Invasive Breast Cancer
NCT00477100
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 was diagnosed with metaplastic breast cancer, carcinosarcoma, sarcoma, neuroendocrine carcinoma, adenoid cystic carcinoma, or phyllodes tumor.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biotheranostics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joyce A O'Shaughnessy, MD
Role: PRINCIPAL_INVESTIGATOR
US Oncology Network
Kai Treuner, PhD
Role: STUDY_DIRECTOR
Biotheranostics, Inc.
Amanda KL Anderson, PhD
Role: STUDY_DIRECTOR
Biotheranostics, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Southern Cancer Center, P.C. - Daphne
Daphne, Alabama, United States
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
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, United States
Illinois Cancer Specialists - Arlington Heights
Arlington Heights, Illinois, United States
Affiliated Oncologists, LLC
Chicago Ridge, Illinois, United States
Illinois Cancer Specialists - Niles
Niles, Illinois, United States
Maryland Oncology Hematology, P.A. - Bethesda
Bethesda, Maryland, United States
Maryland Oncology Hematology, P.A. - Brandywine
Brandywine, Maryland, United States
Maryland Oncology Hematology, P.A. - Clinton
Clinton, Maryland, United States
Maryland Oncology Hematology, P.A. - Columbia
Columbia, Maryland, United States
Maryland Oncology Hematology, P.A. - Frederick
Frederick, Maryland, United States
Maryland Oncology Hematology, P.A. - Lanham
Lanham, Maryland, United States
Maryland Oncology Hematology, P.A. - Rockville - Aquilino Cancer Center
Rockville, Maryland, United States
Maryland Oncology Hematology, P.A. - Silver Spring - White Oak Cancer Center
Silver Spring, Maryland, United States
New York Oncology Hematology, P.C. - Albany Cancer Center
Albany, New York, United States
New York Oncology Hematology, P.C. - Albany Medical Center
Albany, New York, United States
Broome Oncology, LLC - Binghamton
Binghamton, New York, United States
New York Oncology Hematology, P.C. - Clifton Park Cancer Center
Clifton Park, New York, United States
Broome Oncology, LLC - Johnson City
Johnson City, New York, United States
Alliance Cancer Specialists, PC
Bensalem, Pennsylvania, United States
Consultants In Medical Oncology and Hematology, P.C.
Broomall, Pennsylvania, United States
Alliance Cancer Specialists, PC
Horsham, Pennsylvania, United States
Alliance Cancer Specialists, PC
Langhorne, Pennsylvania, United States
Alliance Cancer Specialists, PC
Philadelphia, Pennsylvania, United States
Alliance Cancer Specialists, PC
Sellersville, Pennsylvania, United States
Alliance Cancer Specialists, PC
Wynnewood, Pennsylvania, United States
Texas Oncology - Abilene
Abilene, Texas, United States
Texas Oncology - Allen
Allen, Texas, United States
Texas Oncology - Amarillo
Amarillo, Texas, United States
Texas Oncology - DFWW
Arlington, Texas, United States
Texas Oncology - DFWW
Arlington, Texas, United States
Texas Oncology - Beaumont
Beaumont, Texas, United States
Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States
Texas Oncology - DFWW
Bedford, Texas, United States
Texas Oncology - Carrollton
Carrollton, Texas, United States
Texas Oncology - DFWW
Dallas, Texas, United States
Texas Oncology - Medical City Dallas
Dallas, Texas, United States
Texas Oncology - Presbyterian Cancer Center Dallas
Dallas, Texas, United States
Texas Oncology - DFWW
Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology - Denison
Denison, Texas, United States
Texas Oncology - Denton
Denton, Texas, United States
Texas Oncology - El Paso Cancer Treatment Center Grandview
El Paso, Texas, United States
Texas Oncology - El Paso Cancer Treatment Center Gateway
El Paso, Texas, United States
Texas Oncology - El Paso Cancer Treatment Center Joe Battle
El Paso, Texas, United States
Texas Oncology - Flower Mound
Flower Mound, Texas, United States
Texas Oncology - DFWW
Grapevine, Texas, United States
Texas Oncology - Harlingen
Harlingen, Texas, United States
Texas Oncology - Memorial City
Houston, Texas, United States
Texas Oncology - Willowbrook
Houston, Texas, United States
Texas Oncology - Northeast Texas
Longview, Texas, United States
Texas Oncology - McAllen
McAllen, Texas, United States
Texas Oncology - McKinney
McKinney, Texas, United States
Texas Oncology - Midland
Midland, Texas, United States
Texas Oncology - New Braunfels
New Braunfels, Texas, United States
Texas Oncology - Odessa
Odessa, Texas, United States
Texas Oncology - Northeast Texas
Palestine, Texas, United States
Texas Oncology - Northeast Texas
Paris, Texas, United States
Texas Oncology - Plano West
Plano, Texas, United States
Texas Oncology - San Antonio Downtown
San Antonio, Texas, United States
Texas Oncology - San Antonio Northeast
San Antonio, Texas, United States
Texas Oncology - San Antonio
San Antonio, Texas, United States
Texas Oncology - San Antonio Stone Oak
San Antonio, Texas, United States
Texas Oncology - Sugar Land
Sugar Land, Texas, United States
Texas Oncology - The Woodlands
The Woodlands, Texas, United States
Texas Oncology - Northeast Texas
Tyler, Texas, United States
Texas Oncology - Austin
Waco, Texas, United States
Texas Oncology - Horizon Circle
Waco, Texas, United States
Texas Oncology - Deke Slayton Cancer Center
Webster, Texas, United States
Texas Oncology - Weslaco
Weslaco, Texas, United States
Texas Oncology - Wichita Falls
Wichita Falls, Texas, United States
Virginia Cancer Specialists, PC - Alexandria
Alexandria, Virginia, United States
Virginia Cancer Specialists, PC - Arlington
Arlington, Virginia, United States
Virginia Oncology Associates
Chesapeake, Virginia, United States
Virginia Cancer Specialists, PC - Fairfax
Fairfax, Virginia, United States
Virginia Cancer Specialists, PC - Gainesville
Gainesville, Virginia, United States
Virginia Cancer Specialists, PC - Loudoun
Leesburg, Virginia, United States
Virginia Oncology Associates
Newport News, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Virginia Oncology Associates
Virginia Beach, Virginia, United States
Virginia Oncology Associates
Williamsburg, Virginia, United States
Shenandoah Oncology, P.C.
Winchester, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Bartlett 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.
Zhang 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.
Sgroi 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.
Sgroi 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BTX-BCI-016-PRT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.