EndoPredict® Extended Endocrine Trial (EXET)

Primary Invasive Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04016935
• Other study ID #: ONC-010
• Status: Terminated
• Start date: July 2, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2022
• Source: Myriad Genetic Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 855
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Primary Invasive Breast Cancer

Intervention

Other:
• Observational
Observational

Locations

Country	Name	City	State
United States	Akron General Medical Center	Akron	Ohio
United States	Summa Health	Akron	Ohio
United States	New York Oncology Hematology	Albany	New York
United States	New York Oncology Hematology	Albany	New York
United States	AON Hematology Oncology Clinic	Baton Rouge	Louisiana
United States	UPMC Hillman Cancer Center Beaver	Beaver	Pennsylvania
United States	UPMC Hillman Cancer Center Upper St. Clair	Bethel Park	Pennsylvania
United States	Providence	Burbank	California
United States	Butler Health System Medical Oncology	Butler	Pennsylvania
United States	New York Oncology Hematology	Clifton Park	New York
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	UPMC Hillman Cancer Center - Moon	Coraopolis	Pennsylvania
United States	UPMC Passavant North Cranberry (OHA)	Cranberry Township	Pennsylvania
United States	Texas Oncology Sammons Cancer Center	Dallas	Texas
United States	Hematology Oncology Associates of Central New York, PC	East Syracuse	New York
United States	UPMC Hillman Cancer Center Erie	Erie	Pennsylvania
United States	UPMC Hillman Cancer Center Horizon	Farrell	Pennsylvania
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	UPMC Hillman Cancer Center Greenville	Greenville	Pennsylvania
United States	UPMC Hillman Cancer Center Indiana	Indiana	Pennsylvania
United States	UPMC Hillman Cancer Center Arnold Palmer at Norwin	Irwin	Pennsylvania
United States	UPMC Hillman Cancer Center Murtha	Johnstown	Pennsylvania
United States	Carolina Blood and Cancer Care Associates	Lancaster	South Carolina
United States	UPMC Hillman Cancer McKeesport	McKeesport	Pennsylvania
United States	Ortenzio Cancer Center	Mechanicsburg	Pennsylvania
United States	Baptist Cancer Center	Memphis	Tennessee
United States	Minnesota Oncology Hematology	Minneapolis	Minnesota
United States	UPMC Hillman Cancer Center Monroeville	Monroeville	Pennsylvania
United States	UPMC Hillman Cancer Center Arnold Palmer at Mt. Pleasant	Mount Pleasant	Pennsylvania
United States	Tennessee Oncology	Nashville	Tennessee
United States	UPMC Hillman Cancer Center - Natrona Heights	Natrona Heights	Pennsylvania
United States	UPMC Hillman Cancer Center New Castle	New Castle	Pennsylvania
United States	Allegheny Health Network	Pittsburgh	Pennsylvania
United States	Magee-Women's Hospital of UPMC	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center (UPMC)	Pittsburgh	Pennsylvania
United States	UPMC - St. Clair Hospital - Integrated Cancer Services	Pittsburgh	Pennsylvania
United States	UPMC Hillman Cancer Center Passavant (HOA)	Pittsburgh	Pennsylvania
United States	UPMC Hillman Cancer Center Passavant (OHA)	Pittsburgh	Pennsylvania
United States	UPMC Hillman Cancer Center St Margaret	Pittsburgh	Pennsylvania
United States	Carolina Blood and Cancer Care Associates	Rock Hill	South Carolina
United States	Sutter Hematology and Oncology	Roseville	California
United States	Florida Cancer Specialists	Saint Petersburg	Florida
United States	UPMC Hillman Cancer Center Northwest	Seneca	Pennsylvania
United States	Florida Cancer Specialists	Tallahassee	Florida
United States	Hope Cancer of Texas	Tyler	Texas
United States	Texas Oncology	Tyler	Texas
United States	UPMC Hillman Cancer Center Uniontown	Uniontown	Pennsylvania
United States	UPMC Hillman Cancer Center Washington	Washington	Pennsylvania
United States	UPMC Hillman Cancer Center Jefferson	West Mifflin	Pennsylvania
United States	Florida Cancer Specialists	West Palm Beach	Florida
United States	UPMC Hillman Cancer Center Williamsport	Williamsport	Pennsylvania
United States	UPMC Memorial	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Myriad Genetic Laboratories, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare previous chemotherapy treatment decisions to chemotherapy treatment recommendations based on EndoPredict® risk classification.	Compare previous chemotherapy treatment decisions to chemotherapy treatment recommendations based on EndoPredict® risk classification.	1 Year
Other	Repeat all primary and secondary objectives in subsets of patients based on variables such as clinicopathologic features and treatment.	Repeat all primary and secondary objectives in subsets of patients based on variables such as clinicopathologic features and treatment.	10 Years
Primary	Evaluate DRFS of women 5-10 years post diagnosis with ER+, HER2-breast cancer who are low risk according to their EPclin scores	The primary objective of this study is to evaluate distant recurrence-free survival (DRFS) between years 5 and 10 post-diagnosis of women with ER+, HER2- breast cancer who are classified as low risk according to their EPclin score and who did not receive extended endocrine therapy	10 Years
Secondary	Evaluate DRFS between years 5 and 10 post-diagnosis in women classified as low risk according to their EPclin who received extended endocrine therapy	Evaluate DRFS between years 5 and 10 post-diagnosis in women classified as low risk according to their EPclin who received extended endocrine therapy	10 Years
Secondary	Evaluate DRFS between years 5 and 10 post-diagnosis in women classified as high risk according to their EPclin score based on treatment decisions.	Evaluate DRFS between years 5 and 10 post-diagnosis in women classified as high risk according to their EPclin score based on treatment decisions.	10 Years
Secondary	Evaluate adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy	Evaluate the proportion of patients classified as EPclin low who forgo extending endocrine and the proportion of EPclin high who extend endocrine therapy beyond 5 years	1 Year
Secondary	Evaluate adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy according to whether patients received adjuvant chemotherapy.	Evaluate the proportion of patients who received adjuvant chemotherapy classified as EPclin low who forgo extending endocrine and those classified as EPclin high who extend endocrine therapy beyond 5 years	1 Year
Secondary	Evaluate disease-free survival in patients stratified based on EPclin risk classification and actual treatment.	Evaluate disease-free survival in patients stratified based on EPclin risk classification and actual treatment.	10 Years