Breast Cancer Index (BCI) Registry

Breast Cancer Clinical Trial

Official title:

Breast Cancer Index (BCI) Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04875351
• Other study ID #: BTX-BCI-016-PRT
• Status: Active, not recruiting
• Start date: April 14, 2021
• Est. completion date: December 2028

Study information

• Verified date: January 2024
• Source: Biotheranostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 part of routine clinical care to inform extended endocrine therapy.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• Patient has distant metastatic disease (M1).

• Patient was diagnosed with metaplastic breast cancer, carcinosarcoma, sarcoma, neuroendocrine carcinoma, adenoid cystic carcinoma, or phyllodes tumor.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	Texas Oncology - Abilene	Abilene	Texas
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	Virginia Cancer Specialists, PC - Alexandria	Alexandria	Virginia
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	Virginia Cancer Specialists, PC - Arlington	Arlington	Virginia
United States	Illinois Cancer Specialists - Arlington Heights	Arlington Heights	Illinois
United States	Rocky Mountain Cancer Center - Aurora	Aurora	Colorado
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	Alliance Cancer Specialists, PC	Bensalem	Pennsylvania
United States	Maryland Oncology Hematology, P.A. - Bethesda	Bethesda	Maryland
United States	Broome Oncology, LLC - Binghamton	Binghamton	New York
United States	Rocky Mountain Cancer Center - Boulder	Boulder	Colorado
United States	Maryland Oncology Hematology, P.A. - Brandywine	Brandywine	Maryland
United States	Consultants In Medical Oncology and Hematology, P.C.	Broomall	Pennsylvania
United States	Texas Oncology - Carrollton	Carrollton	Texas
United States	Rocky Mountain Cancer Center - Centennial	Centennial	Colorado
United States	Virginia Oncology Associates	Chesapeake	Virginia
United States	Affiliated Oncologists, LLC	Chicago Ridge	Illinois
United States	New York Oncology Hematology, P.C. - Clifton Park Cancer Center	Clifton Park	New York
United States	Maryland Oncology Hematology, P.A. - Clinton	Clinton	Maryland
United States	Rocky Mountain Cancer Center - Colorado Springs	Colorado Springs	Colorado
United States	Maryland Oncology Hematology, P.A. - Columbia	Columbia	Maryland
United States	Texas Oncology - Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Texas Oncology - DFWW	Dallas	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	Southern Cancer Center, P.C. - Daphne	Daphne	Alabama
United States	Texas Oncology - Denison	Denison	Texas
United States	Texas Oncology - Denton	Denton	Texas
United States	Rocky Mountain Cancer Center - Denver	Denver	Colorado
United States	Rocky Mountain Cancer Center - Denver Midtown	Denver	Colorado
United States	Texas Oncology - El Paso Cancer Treatment Center Gateway	El Paso	Texas
United States	Texas Oncology - El Paso Cancer Treatment Center Grandview	El Paso	Texas
United States	Texas Oncology - El Paso Cancer Treatment Center Joe Battle	El Paso	Texas
United States	Rocky Mountain Cancer Center - Swedish Medical Center	Englewood	Colorado
United States	Virginia Cancer Specialists, PC - Fairfax	Fairfax	Virginia
United States	Texas Oncology - Flower Mound	Flower Mound	Texas
United States	Maryland Oncology Hematology, P.A. - Frederick	Frederick	Maryland
United States	Virginia Cancer Specialists, PC - Gainesville	Gainesville	Virginia
United States	Arizona Oncology Associates, PC - Glendale - Saguaro Cancer Center	Glendale	Arizona
United States	Arizona Oncology Associates, PC - Goodyear	Goodyear	Arizona
United States	Texas Oncology - DFWW	Grapevine	Texas
United States	Texas Oncology - Harlingen	Harlingen	Texas
United States	Alliance Cancer Specialists, PC	Horsham	Pennsylvania
United States	Texas Oncology - Memorial City	Houston	Texas
United States	Texas Oncology - Willowbrook	Houston	Texas
United States	Broome Oncology, LLC - Johnson City	Johnson City	New York
United States	Rocky Mountain Cancer Centers - Lakewood	Lakewood	Colorado
United States	Alliance Cancer Specialists, PC	Langhorne	Pennsylvania
United States	Maryland Oncology Hematology, P.A. - Lanham	Lanham	Maryland
United States	Virginia Cancer Specialists, PC - Loudoun	Leesburg	Virginia
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	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	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	Texas Oncology - New Braunfels	New Braunfels	Texas
United States	Virginia Oncology Associates	Newport News	Virginia
United States	Illinois Cancer Specialists - Niles	Niles	Illinois
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Texas Oncology - Odessa	Odessa	Texas
United States	Texas Oncology - Northeast Texas	Palestine	Texas
United States	Cancer Care Centers of Brevard, Inc.	Palm Bay	Florida
United States	Texas Oncology - Northeast Texas	Paris	Texas
United States	Alliance Cancer Specialists, PC	Philadelphia	Pennsylvania
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	Texas Oncology - Plano West	Plano	Texas
United States	Rocky Mountain Cancer Center - Pueblo	Pueblo	Colorado
United States	Maryland Oncology Hematology, P.A. - Rockville - Aquilino Cancer Center	Rockville	Maryland
United States	Texas Oncology - San Antonio	San Antonio	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 Stone Oak	San Antonio	Texas
United States	Sansum Clinic - Ridley-Tree Cancer Center	Santa Barbara	California
United States	Arizona Oncology Associates, PC - Scottsdale	Scottsdale	Arizona
United States	Alliance Cancer Specialists, PC	Sellersville	Pennsylvania
United States	Maryland Oncology Hematology, P.A. - Silver Spring - White Oak Cancer Center	Silver Spring	Maryland
United States	Sansum Clinic - Ridley-Tree Cancer Center (Solvang)	Solvang	California
United States	Texas Oncology - Sugar Land	Sugar Land	Texas
United States	Arizona Oncology Associates, PC - East Valley Cancer Center	Tempe	Arizona
United States	Texas Oncology - The Woodlands	The Woodlands	Texas
United States	Rocky Mountain Cancer Center - Thornton	Thornton	Colorado
United States	Texas Oncology - Northeast Texas	Tyler	Texas
United States	Virginia Oncology Associates	Virginia Beach	Virginia
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 Oncology Associates	Williamsburg	Virginia
United States	Shenandoah Oncology, P.C.	Winchester	Virginia
United States	Alliance Cancer Specialists, PC	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Biotheranostics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Lancet Oncol. 2018 Apr;19(4):e184. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine BCI test performance by evaluating the long-term outcome of BCI risk groups over the follow-up period.		5 Years
Primary	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	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.	5 Years
Secondary	To correlate BCI results with molecular tumor profiles in early stage breast cancer.		5 Years