⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Breast Cancer Index (BCI) Registry

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Breast Cancer Index (BCI) Registry

Official Title: Breast Cancer Index (BCI) Registry

Study ID: NCT04875351

Conditions

Breast Cancer

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.

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Joyce A O'Shaughnessy, MD

Affiliation: US Oncology Network

Role: PRINCIPAL_INVESTIGATOR

Name: Kai Treuner, PhD

Affiliation: Biotheranostics, Inc.

Role: STUDY_DIRECTOR

Name: Amanda KL Anderson, PhD

Affiliation: Biotheranostics, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: