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Breast CancerNCT04875351

Breast Cancer Index (BCI) Registry

An observational study of Breast Cancer, run by Biotheranostics, Inc. at 105 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit Test
How many people
3,465 participants
Where
105 sitesUnited States
Study dates
14 Apr 2021to Dec 2028
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

105 sites in 1 country.

105 sites in 1 country

United States105 sites

  • Texas Oncology - Abilene

    Abilene, Texas, 79606

  • New York Oncology Hematology, P.C. - Albany Cancer Center

    Albany, New York, 12206

  • New York Oncology Hematology, P.C. - Albany Medical Center

    Albany, New York, 12208

  • Virginia Cancer Specialists, PC - Alexandria

    Alexandria, Virginia, 22304

  • Texas Oncology - Allen

    Allen, Texas, 75013

  • Texas Oncology - Amarillo

    Amarillo, Texas, 79106

  • Texas Oncology - DFWW

    Arlington, Texas, 76012

  • Texas Oncology - DFWW

    Arlington, Texas, 76014

  • Virginia Cancer Specialists, PC - Arlington

    Arlington, Virginia, 22205

  • Illinois Cancer Specialists - Arlington Heights

    Arlington Heights, Illinois, 60005

  • Rocky Mountain Cancer Center - Aurora

    Aurora, Colorado, 80012

  • Texas Oncology - Beaumont

    Beaumont, Texas, 77701

  • Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • Texas Oncology - DFWW

    Bedford, Texas, 76022

  • Alliance Cancer Specialists, PC

    Bensalem, Pennsylvania, 19020

  • Maryland Oncology Hematology, P.A. - Bethesda

    Bethesda, Maryland, 20817

  • Broome Oncology, LLC - Binghamton

    Binghamton, New York, 13905

  • Rocky Mountain Cancer Center - Boulder

    Boulder, Colorado, 80303

  • Maryland Oncology Hematology, P.A. - Brandywine

    Brandywine, Maryland, 20613

  • Consultants In Medical Oncology and Hematology, P.C.

    Broomall, Pennsylvania, 19008

  • Texas Oncology - Carrollton

    Carrollton, Texas, 75010

  • Rocky Mountain Cancer Center - Centennial

    Centennial, Colorado, 80112

  • Virginia Oncology Associates

    Chesapeake, Virginia, 23320

  • Affiliated Oncologists, LLC

    Chicago Ridge, Illinois, 60415

  • New York Oncology Hematology, P.C. - Clifton Park Cancer Center

    Clifton Park, New York, 12065

  • Maryland Oncology Hematology, P.A. - Clinton

    Clinton, Maryland, 20735

  • Rocky Mountain Cancer Center - Colorado Springs

    Colorado Springs, Colorado, 80907

  • Maryland Oncology Hematology, P.A. - Columbia

    Columbia, Maryland, 21044

  • Texas Oncology - DFWW

    Dallas, Texas, 75203

  • Texas Oncology - Medical City Dallas

    Dallas, Texas, 75230

  • Texas Oncology - Presbyterian Cancer Center Dallas

    Dallas, Texas, 75231

  • Texas Oncology - DFWW

    Dallas, Texas, 75237

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Southern Cancer Center, P.C. - Daphne

    Daphne, Alabama, 36526

  • Texas Oncology - Denison

    Denison, Texas, 75020

  • Texas Oncology - Denton

    Denton, Texas, 76201

  • Rocky Mountain Cancer Center - Denver Midtown

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Center - Denver

    Denver, Colorado, 80220

  • Texas Oncology - El Paso Cancer Treatment Center Grandview

    El Paso, Texas, 79902

  • Texas Oncology - El Paso Cancer Treatment Center Gateway

    El Paso, Texas, 79915

  • Texas Oncology - El Paso Cancer Treatment Center Joe Battle

    El Paso, Texas, 79938

  • Rocky Mountain Cancer Center - Swedish Medical Center

    Englewood, Colorado, 80113

  • Virginia Cancer Specialists, PC - Fairfax

    Fairfax, Virginia, 22031

  • Texas Oncology - Flower Mound

    Flower Mound, Texas, 75028

  • Maryland Oncology Hematology, P.A. - Frederick

    Frederick, Maryland, 21702

  • Virginia Cancer Specialists, PC - Gainesville

    Gainesville, Virginia, 20155

  • Arizona Oncology Associates, PC - Glendale - Saguaro Cancer Center

    Glendale, Arizona, 85308

  • Arizona Oncology Associates, PC - Goodyear

    Goodyear, Arizona, 85395

  • Texas Oncology - DFWW

    Grapevine, Texas, 76051

  • Texas Oncology - Harlingen

    Harlingen, Texas, 78550

  • Alliance Cancer Specialists, PC

    Horsham, Pennsylvania, 19044

  • Texas Oncology - Memorial City

    Houston, Texas, 77024

  • Texas Oncology - Willowbrook

    Houston, Texas, 77070

  • Broome Oncology, LLC - Johnson City

    Johnson City, New York, 13790

  • Rocky Mountain Cancer Centers - Lakewood

    Lakewood, Colorado, 80228

  • Alliance Cancer Specialists, PC

    Langhorne, Pennsylvania, 19047

  • Maryland Oncology Hematology, P.A. - Lanham

    Lanham, Maryland, 20706

  • Virginia Cancer Specialists, PC - Loudoun

    Leesburg, Virginia, 20176

  • Rocky Mountain Cancer Center - Littleton

    Littleton, Colorado, 80120

  • Rocky Mountain Cancer Center - Lone Tree

    Lone Tree, Colorado, 80124

  • Rocky Mountain Cancer Center - Longmont

    Longmont, Colorado, 80504

  • Texas Oncology - Northeast Texas

    Longview, Texas, 75601

  • Texas Oncology - McAllen

    McAllen, Texas, 78503

  • Texas Oncology - McKinney

    McKinney, Texas, 75071

  • Texas Oncology - Midland

    Midland, Texas, 79701

  • Southern Cancer Center, PC - Mobile Infirmary

    Mobile, Alabama, 36607

  • Southern Cancer Center, PC - Providence Hospital

    Mobile, Alabama, 36608

  • Southern Cancer Center, PC - Springhill Medical Center

    Mobile, Alabama, 36608

  • Texas Oncology - New Braunfels

    New Braunfels, Texas, 78130

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Illinois Cancer Specialists - Niles

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Texas Oncology - Odessa

    Odessa, Texas, 79761

  • Texas Oncology - Northeast Texas

    Palestine, Texas, 75801

  • Cancer Care Centers of Brevard, Inc.

    Palm Bay, Florida, 32901

  • Texas Oncology - Northeast Texas

    Paris, Texas, 75460

  • Alliance Cancer Specialists, PC

    Philadelphia, Pennsylvania, 19115

  • Arizona Oncology Associates, PC - Phoenix - Biltmore Cancer Center

    Phoenix, Arizona, 85016

  • Arizona Oncology Associates, PC - Phoenix - Deer Valley

    Phoenix, Arizona, 85027

  • Texas Oncology - Plano West

    Plano, Texas, 75093

  • Rocky Mountain Cancer Center - Pueblo

    Pueblo, Colorado, 81003

  • Maryland Oncology Hematology, P.A. - Rockville - Aquilino Cancer Center

    Rockville, Maryland, 20850

  • Texas Oncology - San Antonio Downtown

    San Antonio, Texas, 78212

  • Texas Oncology - San Antonio Northeast

    San Antonio, Texas, 78217

  • Texas Oncology - San Antonio

    San Antonio, Texas, 78240

  • Texas Oncology - San Antonio Stone Oak

    San Antonio, Texas, 78258

  • Sansum Clinic - Ridley-Tree Cancer Center

    Santa Barbara, California, 93105

  • Arizona Oncology Associates, PC - Scottsdale

    Scottsdale, Arizona, 85258

  • Alliance Cancer Specialists, PC

    Sellersville, Pennsylvania, 18960

  • Maryland Oncology Hematology, P.A. - Silver Spring - White Oak Cancer Center

    Silver Spring, Maryland, 20904

  • Sansum Clinic - Ridley-Tree Cancer Center (Solvang)

    Solvang, California, 93463

  • Texas Oncology - Sugar Land

    Sugar Land, Texas, 77479

  • Arizona Oncology Associates, PC - East Valley Cancer Center

    Tempe, Arizona, 85284

  • Texas Oncology - The Woodlands

    The Woodlands, Texas, 77380

  • Rocky Mountain Cancer Center - Thornton

    Thornton, Colorado, 80260

  • Texas Oncology - Northeast Texas

    Tyler, Texas, 75702

  • Virginia Oncology Associates

    Virginia Beach, Virginia, 23456

  • Texas Oncology - Austin

    Waco, Texas, 76712

  • Texas Oncology - Horizon Circle

    Waco, Texas, 76712

  • Texas Oncology - Deke Slayton Cancer Center

    Webster, Texas, 77598

  • Texas Oncology - Weslaco

    Weslaco, Texas, 78596

  • Texas Oncology - Wichita Falls

    Wichita Falls, Texas, 76310

  • Virginia Oncology Associates

    Williamsburg, Virginia, 23188

  • Shenandoah Oncology, P.C.

    Winchester, Virginia, 22601

  • Alliance Cancer Specialists, PC

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

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.

Read the 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 primary adjuvant endocrine therapy and are considering extended endocrine treatment. The impact of BCI test results on extended endocrine therapy decision-making and clinical use patterns will be characterized. Extended endocrine therapy-specific medication adherence will be assessed annually. Primary tumor tissue will be collected for scientific research purposes including molecular profiling and for correlative studies. The sample size will consist of approximately 3,000 subjects across 30-50 sites in the United States.

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
Breast Cancer
Being tested
Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit Test
Keywords
Breast Neoplasm, Invasive Breast Carcinoma, Early Stage (I, II or III) Breast Cancer, Hormone Receptor positive (HR+) Breast Cancer, Extended Endocrine Therapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit TestDiagnostic test

    Also called Breast Cancer Index (BCI) 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.

Study groups in NCT04875351
Study groupRoleWhat they receive
Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit TestingFemale 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.
Receives: Diagnostic Test: Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine BCI test performance by evaluating the long-term outcome of BCI risk groups over the follow-up period.

    Measured: 5 Years

  2. 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.

    Measured: 5 Years

Secondary outcomes (2)

  1. To prospectively assess the impact of BCI on extended endocrine therapy decision-making.

    The impact of the BCI test results on extended endocrine therapy decision making will be measured using pre- and post-test Decision Impact Questionnaires, which will be completed by both physicians and patients.

    Measured: 5 Years

  2. To correlate BCI results with molecular tumor profiles in early stage breast cancer.

    Measured: 5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2021
  2. Study start14 Apr 2021
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
3,465 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04875351
Sponsor's protocol ID
BTX-BCI-016-PRT
Status last verified
Sep 2024
First submitted
26 Apr 2021
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33109739

  • 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.

    PubMed 31504126

  • 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.

    PubMed 23757354

  • 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.

    PubMed 24035531

  • 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.

    PubMed 23812955

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Biotheranostics, Inc. at 105 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine BCI test performance by evaluating the long-term outcome of BCI risk groups over the follow-up period. (time frame: 5 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04875351, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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