Breast Cancer Index (BCI) Registry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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. [5 Years]
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.
Secondary Outcome Measures
- To prospectively assess the impact of BCI on extended endocrine therapy decision-making. [5 Years]
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.
- To correlate BCI results with molecular tumor profiles in early stage breast cancer. [5 Years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Early stage (I, II or III) female breast cancer patients, who have completed 4-7 years of primary adjuvant endocrine therapy
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Patient was diagnosed with invasive breast carcinoma (ductal, lobular, or mixed ductal/lobular).
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The primary tumor was hormone receptor positive (HR+), i.e. estrogen receptor-positive and/or progesterone receptor-positive.
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The primary tumor was HER2 negative or positive and node-negative or node-positive with 1-3 positive lymph nodes.
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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).
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Patient was diagnosed with metaplastic breast cancer, carcinosarcoma, sarcoma, neuroendocrine carcinoma, adenoid cystic carcinoma, or phyllodes tumor.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
| 5 | Arizona Oncology Associates, PC - Glendale - Saguaro Cancer Center | Glendale | Arizona | United States | 85308 |
| 6 | Arizona Oncology Associates, PC - Goodyear | Goodyear | Arizona | United States | 85395 |
| 7 | Arizona Oncology Associates, PC - Phoenix - Biltmore Cancer Center | Phoenix | Arizona | United States | 85016 |
| 8 | Arizona Oncology Associates, PC - Phoenix - Deer Valley | Phoenix | Arizona | United States | 85027 |
| 9 | Arizona Oncology Associates, PC - Scottsdale | Scottsdale | Arizona | United States | 85258 |
| 10 | Arizona Oncology Associates, PC - East Valley Cancer Center | Tempe | Arizona | United States | 85284 |
| 11 | Sansum Clinic - Ridley-Tree Cancer Center | Santa Barbara | California | United States | 93105 |
| 12 | Sansum Clinic - Ridley-Tree Cancer Center (Solvang) | Solvang | California | United States | 93463 |
| 13 | Rocky Mountain Cancer Center - Aurora | Aurora | Colorado | United States | 80012 |
| 14 | Rocky Mountain Cancer Center - Boulder | Boulder | Colorado | United States | 80303 |
| 15 | Rocky Mountain Cancer Center - Centennial | Centennial | Colorado | United States | 80112 |
| 16 | Rocky Mountain Cancer Center - Colorado Springs | Colorado Springs | Colorado | United States | 80907 |
| 17 | Rocky Mountain Cancer Center - Denver Midtown | Denver | Colorado | United States | 80218 |
| 18 | Rocky Mountain Cancer Center - Denver | Denver | Colorado | United States | 80220 |
| 19 | Rocky Mountain Cancer Center - Swedish Medical Center | Englewood | Colorado | United States | 80113 |
| 20 | Rocky Mountain Cancer Centers - Lakewood | Lakewood | Colorado | United States | 80228 |
| 21 | Rocky Mountain Cancer Center - Littleton | Littleton | Colorado | United States | 80120 |
| 22 | Rocky Mountain Cancer Center - Lone Tree | Lone Tree | Colorado | United States | 80124 |
| 23 | Rocky Mountain Cancer Center - Longmont | Longmont | Colorado | United States | 80501 |
| 24 | Rocky Mountain Cancer Center - Pueblo | Pueblo | Colorado | United States | 81008 |
| 25 | Rocky Mountain Cancer Center - Thornton | Thornton | Colorado | United States | 80260 |
| 26 | Cancer Care Centers of Brevard, Inc. | Palm Bay | Florida | United States | 32901 |
| 27 | Illinois Cancer Specialists - Arlington Heights | Arlington Heights | Illinois | United States | 60005 |
| 28 | Affiliated Oncologists, LLC | Chicago Ridge | Illinois | United States | 60415 |
| 29 | Illinois Cancer Specialists - Niles | Niles | Illinois | United States | 60714 |
| 30 | Maryland Oncology Hematology, P.A. - Bethesda | Bethesda | Maryland | United States | 20817 |
| 31 | Maryland Oncology Hematology, P.A. - Brandywine | Brandywine | Maryland | United States | 20613 |
| 32 | Maryland Oncology Hematology, P.A. - Clinton | Clinton | Maryland | United States | 20735 |
| 33 | Maryland Oncology Hematology, P.A. - Columbia | Columbia | Maryland | United States | 21044 |
| 34 | Maryland Oncology Hematology, P.A. - Frederick | Frederick | Maryland | United States | 21702 |
| 35 | Maryland Oncology Hematology, P.A. - Lanham | Lanham | Maryland | United States | 20706 |
| 36 | Maryland Oncology Hematology, P.A. - Rockville - Aquilino Cancer Center | Rockville | Maryland | United States | 20850 |
| 37 | Maryland Oncology Hematology, P.A. - Silver Spring - White Oak Cancer Center | Silver Spring | Maryland | United States | 20904 |
| 38 | New York Oncology Hematology, P.C. - Albany Cancer Center | Albany | New York | United States | 12206 |
| 39 | New York Oncology Hematology, P.C. - Albany Medical Center | Albany | New York | United States | 12208 |
| 40 | Broome Oncology, LLC - Binghamton | Binghamton | New York | United States | 13905 |
| 41 | New York Oncology Hematology, P.C. - Clifton Park Cancer Center | Clifton Park | New York | United States | 12065 |
| 42 | Broome Oncology, LLC - Johnson City | Johnson City | New York | United States | 13790 |
| 43 | Alliance Cancer Specialists, PC | Bensalem | Pennsylvania | United States | 19020 |
| 44 | Consultants In Medical Oncology and Hematology, P.C. | Broomall | Pennsylvania | United States | 19008 |
| 45 | Alliance Cancer Specialists, PC | Horsham | Pennsylvania | United States | 19044 |
| 46 | Alliance Cancer Specialists, PC | Langhorne | Pennsylvania | United States | 19047 |
| 47 | Alliance Cancer Specialists, PC | Philadelphia | Pennsylvania | United States | 19115 |
| 48 | Alliance Cancer Specialists, PC | Sellersville | Pennsylvania | United States | 18960 |
| 49 | Alliance Cancer Specialists, PC | Wynnewood | Pennsylvania | United States | 19096 |
| 50 | Texas Oncology - Abilene | Abilene | Texas | United States | 79606 |
| 51 | Texas Oncology - Allen | Allen | Texas | United States | 75013 |
| 52 | Texas Oncology - Amarillo | Amarillo | Texas | United States | 79106 |
| 53 | Texas Oncology - DFWW | Arlington | Texas | United States | 76012 |
| 54 | Texas Oncology - DFWW | Arlington | Texas | United States | 76014 |
| 55 | Texas Oncology - Beaumont | Beaumont | Texas | United States | 77701 |
| 56 | Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center | Beaumont | Texas | United States | 77702 |
| 57 | Texas Oncology - DFWW | Bedford | Texas | United States | 76022 |
| 58 | Texas Oncology - Carrollton | Carrollton | Texas | United States | 75010 |
| 59 | Texas Oncology - DFWW | Dallas | Texas | United States | 75203 |
| 60 | Texas Oncology - Medical City Dallas | Dallas | Texas | United States | 75230 |
| 61 | Texas Oncology - Presbyterian Cancer Center Dallas | Dallas | Texas | United States | 75231 |
| 62 | Texas Oncology - DFWW | Dallas | Texas | United States | 75237 |
| 63 | Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | United States | 75246 |
| 64 | Texas Oncology - Denison | Denison | Texas | United States | 75020 |
| 65 | Texas Oncology - Denton | Denton | Texas | United States | 76201 |
| 66 | Texas Oncology - El Paso Cancer Treatment Center Grandview | El Paso | Texas | United States | 79902 |
| 67 | Texas Oncology - El Paso Cancer Treatment Center Gateway | El Paso | Texas | United States | 79915 |
| 68 | Texas Oncology - El Paso Cancer Treatment Center Joe Battle | El Paso | Texas | United States | 79938 |
| 69 | Texas Oncology - Flower Mound | Flower Mound | Texas | United States | 75028 |
| 70 | Texas Oncology - DFWW | Grapevine | Texas | United States | 76051 |
| 71 | Texas Oncology - Harlingen | Harlingen | Texas | United States | 78550 |
| 72 | Texas Oncology - Memorial City | Houston | Texas | United States | 77024 |
| 73 | Texas Oncology - Willowbrook | Houston | Texas | United States | 77070 |
| 74 | Texas Oncology - Northeast Texas | Longview | Texas | United States | 75601 |
| 75 | Texas Oncology - McAllen | McAllen | Texas | United States | 78503 |
| 76 | Texas Oncology - McKinney | McKinney | Texas | United States | 75071 |
| 77 | Texas Oncology - Midland | Midland | Texas | United States | 79701 |
| 78 | Texas Oncology - New Braunfels | New Braunfels | Texas | United States | 78130 |
| 79 | Texas Oncology - Odessa | Odessa | Texas | United States | 79761 |
| 80 | Texas Oncology - Northeast Texas | Palestine | Texas | United States | 75801 |
| 81 | Texas Oncology - Northeast Texas | Paris | Texas | United States | 75460 |
| 82 | Texas Oncology - Plano West | Plano | Texas | United States | 75093 |
| 83 | Texas Oncology - San Antonio Downtown | San Antonio | Texas | United States | 78212 |
| 84 | Texas Oncology - San Antonio Northeast | San Antonio | Texas | United States | 78217 |
| 85 | Texas Oncology - San Antonio | San Antonio | Texas | United States | 78240 |
| 86 | Texas Oncology - San Antonio Stone Oak | San Antonio | Texas | United States | 78258 |
| 87 | Texas Oncology - Sugar Land | Sugar Land | Texas | United States | 77479 |
| 88 | Texas Oncology - The Woodlands | The Woodlands | Texas | United States | 77380 |
| 89 | Texas Oncology - Northeast Texas | Tyler | Texas | United States | 75702 |
| 90 | Texas Oncology - Austin | Waco | Texas | United States | 76712 |
| 91 | Texas Oncology - Horizon Circle | Waco | Texas | United States | 76712 |
| 92 | Texas Oncology - Deke Slayton Cancer Center | Webster | Texas | United States | 77598 |
| 93 | Texas Oncology - Weslaco | Weslaco | Texas | United States | 78596 |
| 94 | Texas Oncology - Wichita Falls | Wichita Falls | Texas | United States | 76310 |
| 95 | Virginia Cancer Specialists, PC - Alexandria | Alexandria | Virginia | United States | 22304 |
| 96 | Virginia Cancer Specialists, PC - Arlington | Arlington | Virginia | United States | 22205 |
| 97 | Virginia Oncology Associates | Chesapeake | Virginia | United States | 23320 |
| 98 | Virginia Cancer Specialists, PC - Fairfax | Fairfax | Virginia | United States | 22031 |
| 99 | Virginia Cancer Specialists, PC - Gainesville | Gainesville | Virginia | United States | 20155 |
| 100 | Virginia Cancer Specialists, PC - Loudoun | Leesburg | Virginia | United States | 20176 |
| 101 | Virginia Oncology Associates | Newport News | Virginia | United States | 23606 |
| 102 | Virginia Oncology Associates | Norfolk | Virginia | United States | 23502 |
| 103 | Virginia Oncology Associates | Virginia Beach | Virginia | United States | 23456 |
| 104 | Virginia Oncology Associates | Williamsburg | Virginia | United States | 23188 |
| 105 | Shenandoah Oncology, P.C. | Winchester | Virginia | United States | 22601 |
Sponsors and Collaborators
- Biotheranostics, Inc.
Investigators
- 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 Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- Zhang Y, Schnabel CA, Schroeder BE, Jerevall PL, Jankowitz RC, Fornander T, Stål 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.
- BTX-BCI-016-PRT