Clinical trial NCT04016935: EndoPredict® Extended Endocrine Trial (EXET)
Official title: EndoPredict® Extended Endocrine Trial (EXET): A Prospective Registry to Evaluate the Impact of EndoPredict® Test on Extended Endocrine Treatment Decisions and Patient Outcomes.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Primary Invasive Breast Cancer
Keywords: ER+ and HER2- Breast Cancer patients
Extended Endocrine Therapy
EndoPredict
Additional Relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lead sponsor: Myriad Genetic Laboratories, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-12
Enrollment: 855
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 2,800 patients with ER+, HER2- breast cancer will be enrolled in this study across multiple sites. These patients will include both node-positive and node negative patients, with a minimum of 1673 patients with low-risk EPclin scores including 1,505 who forego extended endocrine therapy. Patients will be eligible for the study if they meet the following inclusion criteria.

Brief summary: The purpose of this study is to evaluate the impact of using EndoPredict® clinically to inform treatment decisions for extended endocrine therapy, and the subsequent impact on patient outcomes.

Detailed description: The EndoPredict® molecular test is validated to predict late distant recurrence after 5 years of endocrine therapy in women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) early stage breast cancer, with or without treatment with adjuvant chemotherapy. The test provides an individualized EPclin score based on the tumor gene expression, tumor size and nodal status, and categorizes patients as High or Low risk of distant recurrence.

The primary objective of this study is to evaluate the distant recurrence-free survival (DRFS) at 5-10 years in patients with ER+/HER2- early stage breast cancer with EPclin Low scores that did not extend endocrine therapy.

Data collection is prospective and patient enrollment is expected to occur over 24 months. The study will enroll patients who are near the 5-year post-diagnosis time point when decisions on extending endocrine therapy are being made. Patient breast cancer tumors, stored from surgical collection after initial diagnosis, will be tested with EndoPredict and a report generated. The provider will convey the report results to the patient and establish a treatment plan to continue or forgo endocrine therapy. Patients will then be followed for 6 years with data collection every year, and outcomes (distant and local disease recurrence, second primary breast cancer, etc.) recorded.

The associations between outcomes and treatment, EPclin score and risk category, EP molecular score, and clinicopathologic features will be investigated in all patients and in subpopulations (node negative, node positive, treated with or without chemotherapy, etc.).

Eligibility criteria: Inclusion Criteria:

* Female
* At least 18 years of age at time of enrollment
* Able to provide informed consent
* ER+, HER2- breast tumor
* Stage T1-T3
* Currently receiving endocrine therapy
* Are between 4 and 6.5 years post-invasive breast cancer diagnosis
* Have all available information to produce an EPclin score, including treatment-naïve tumor stage, nodal status, and sufficient amount of remaining tissue from biopsy or resection to perform genomic testing (section 9)
* Patient and physician are willing to consider a change in endocrine therapy

Exclusion Criteria:

* Metastatic disease or currently active additional cancer diagnosis (except non- melanoma skin cancer) or any second primary breast cancer (includes ductal and/or lobular carcinoma in situ)
* Patient received systemic chemotherapy within 1 year of enrollment
* Currently enrolled in an interventional clinical trial or other clinical trial that precludes freely making decisions regarding extended endocrine therapy
* More than 3 positive nodes
* Received neo-adjuvant treatment (new-adjuvant chemotherapy or neo-adjuvant endocrine therapy)
* Are beyond 7 years post-breast cancer diagnosis

Primary outcomes:
measure: Evaluate DRFS of women 5-10 years post diagnosis with ER+, HER2-breast cancer who are low risk according to their EPclin scores
timeFrame: 10 Years
Secondary outcomes:
measure: Evaluate DRFS between years 5 and 10 post-diagnosis in women classified as low risk according to their EPclin who received extended endocrine therapy
timeFrame: 10 Years
measure: Evaluate DRFS between years 5 and 10 post-diagnosis in women classified as high risk according to their EPclin score based on treatment decisions.
timeFrame: 10 Years
measure: Evaluate adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy
timeFrame: 1 Year
measure: Evaluate adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy according to whether patients received adjuvant chemotherapy.
timeFrame: 1 Year
measure: Evaluate disease-free survival in patients stratified based on EPclin risk classification and actual treatment.
timeFrame: 10 Years
Other outcomes:
measure: Compare previous chemotherapy treatment decisions to chemotherapy treatment recommendations based on EndoPredict® risk classification.
timeFrame: 1 Year
measure: Repeat all primary and secondary objectives in subsets of patients based on variables such as clinicopathologic features and treatment.
timeFrame: 10 Years
Locations:
city: Burbank
country: United States
facility: Providence
state: California
city: Roseville
country: United States
facility: Sutter Hematology and Oncology
state: California
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tallahassee
country: United States
facility: Florida Cancer Specialists
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Baton Rouge
country: United States
facility: AON Hematology Oncology Clinic
state: Louisiana
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology
state: Minnesota
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: Clifton Park
country: United States
facility: New York Oncology Hematology
state: New York
city: East Syracuse
country: United States
facility: Hematology Oncology Associates of Central New York, PC
state: New York
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Akron
country: United States
facility: Summa Health
state: Ohio
city: Beaver
country: United States
facility: UPMC Hillman Cancer Center Beaver
state: Pennsylvania
city: Bethel Park
country: United States
facility: UPMC Hillman Cancer Center Upper St. Clair
state: Pennsylvania
city: Butler
country: United States
facility: Butler Health System Medical Oncology
state: Pennsylvania
city: Coraopolis
country: United States
facility: UPMC Hillman Cancer Center - Moon
state: Pennsylvania
city: Cranberry Township
country: United States
facility: UPMC Passavant North Cranberry (OHA)
state: Pennsylvania
city: Erie
country: United States
facility: UPMC Hillman Cancer Center Erie
state: Pennsylvania
city: Farrell
country: United States
facility: UPMC Hillman Cancer Center Horizon
state: Pennsylvania
city: Greenville
country: United States
facility: UPMC Hillman Cancer Center Greenville
state: Pennsylvania
city: Indiana
country: United States
facility: UPMC Hillman Cancer Center Indiana
state: Pennsylvania
city: Irwin
country: United States
facility: UPMC Hillman Cancer Center Arnold Palmer at Norwin
state: Pennsylvania
city: Johnstown
country: United States
facility: UPMC Hillman Cancer Center Murtha
state: Pennsylvania
city: McKeesport
country: United States
facility: UPMC Hillman Cancer McKeesport
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: Ortenzio Cancer Center
state: Pennsylvania
city: Monroeville
country: United States
facility: UPMC Hillman Cancer Center Monroeville
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: UPMC Hillman Cancer Center Arnold Palmer at Mt. Pleasant
state: Pennsylvania
city: Natrona Heights
country: United States
facility: UPMC Hillman Cancer Center - Natrona Heights
state: Pennsylvania
city: New Castle
country: United States
facility: UPMC Hillman Cancer Center New Castle
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Women's Hospital of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center St Margaret
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center Passavant (HOA)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center Passavant (OHA)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC - St. Clair Hospital - Integrated Cancer Services
state: Pennsylvania
city: Seneca
country: United States
facility: UPMC Hillman Cancer Center Northwest
state: Pennsylvania
city: Uniontown
country: United States
facility: UPMC Hillman Cancer Center Uniontown
state: Pennsylvania
city: Washington
country: United States
facility: UPMC Hillman Cancer Center Washington
state: Pennsylvania
city: West Mifflin
country: United States
facility: UPMC Hillman Cancer Center Jefferson
state: Pennsylvania
city: Williamsport
country: United States
facility: UPMC Hillman Cancer Center Williamsport
state: Pennsylvania
city: York
country: United States
facility: UPMC Memorial
state: Pennsylvania
city: Lancaster
country: United States
facility: Carolina Blood and Cancer Care Associates
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care Associates
state: South Carolina
city: Memphis
country: United States
facility: Baptist Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology Sammons Cancer Center
state: Texas
city: Tyler
country: United States
facility: Hope Cancer of Texas
state: Texas
city: Tyler
country: United States
facility: Texas Oncology
state: Texas
Study officials:
affiliation: US Oncology
name: Joyce O'Shaunessey, MD
role: PRINCIPAL_INVESTIGATOR
References: