Primary Invasive Breast CancerNCT04016935
EndoPredict® Extended Endocrine Trial (EXET)
An observational study of Primary Invasive Breast Cancer, run by Myriad Genetic Laboratories, Inc. at 52 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Invasive Breast Cancer
- What is being tested?
- Observational
- How many people
- 855 participants
- Where
- 52 sitesUnited States
- Study dates
- 2 Jul 2019to 31 Mar 2022
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
52 sites in 1 country.
52 sites in 1 country
United States52 sites
Akron General Medical Center
Akron, Ohio, 44302
Summa Health
Akron, Ohio, 44304
New York Oncology Hematology
Albany, New York, 12206
New York Oncology Hematology
Albany, New York, 12208
AON Hematology Oncology Clinic
Baton Rouge, Louisiana, 70809
UPMC Hillman Cancer Center Beaver
Beaver, Pennsylvania, 15009
UPMC Hillman Cancer Center Upper St. Clair
Bethel Park, Pennsylvania, 15102
Providence
Burbank, California, 91505
Butler Health System Medical Oncology
Butler, Pennsylvania, 16001
New York Oncology Hematology
Clifton Park, New York, 12065
Columbus Regional Research Institute
Columbus, Georgia, 31904
UPMC Hillman Cancer Center - Moon
Coraopolis, Pennsylvania, 15108
UPMC Passavant North Cranberry (OHA)
Cranberry Township, Pennsylvania, 16066
Texas Oncology Sammons Cancer Center
Dallas, Texas, 75246
Hematology Oncology Associates of Central New York, PC
East Syracuse, New York, 13057
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
UPMC Hillman Cancer Center Horizon
Farrell, Pennsylvania, 16121
Florida Cancer Specialists
Fort Myers, Florida, 33901
UPMC Hillman Cancer Center Greenville
Greenville, Pennsylvania, 16125
UPMC Hillman Cancer Center Indiana
Indiana, Pennsylvania, 15701
UPMC Hillman Cancer Center Arnold Palmer at Norwin
Irwin, Pennsylvania, 15642
UPMC Hillman Cancer Center Murtha
Johnstown, Pennsylvania, 15901
Carolina Blood and Cancer Care Associates
Lancaster, South Carolina, 29732
UPMC Hillman Cancer McKeesport
McKeesport, Pennsylvania, 15132
Ortenzio Cancer Center
Mechanicsburg, Pennsylvania, 17050
Baptist Cancer Center
Memphis, Tennessee, 38120
Minnesota Oncology Hematology
Minneapolis, Minnesota, 55404
UPMC Hillman Cancer Center Monroeville
Monroeville, Pennsylvania, 15146
UPMC Hillman Cancer Center Arnold Palmer at Mt. Pleasant
Mount Pleasant, Pennsylvania, 15666
Tennessee Oncology
Nashville, Tennessee, 37203
UPMC Hillman Cancer Center - Natrona Heights
Natrona Heights, Pennsylvania, 15065
UPMC Hillman Cancer Center New Castle
New Castle, Pennsylvania, 16105
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Magee-Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213
UPMC Hillman Cancer Center St Margaret
Pittsburgh, Pennsylvania, 15215
UPMC Hillman Cancer Center Passavant (HOA)
Pittsburgh, Pennsylvania, 15237
UPMC Hillman Cancer Center Passavant (OHA)
Pittsburgh, Pennsylvania, 15237
UPMC - St. Clair Hospital - Integrated Cancer Services
Pittsburgh, Pennsylvania, 15243
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, 29732
Sutter Hematology and Oncology
Roseville, California, 95661
UPMC Hillman Cancer Center Northwest
Seneca, Pennsylvania, 16346
Florida Cancer Specialists
St. Petersburg, Florida, 33705
Florida Cancer Specialists
Tallahassee, Florida, 32308
Hope Cancer of Texas
Tyler, Texas, 75701
Texas Oncology
Tyler, Texas, 75702
UPMC Hillman Cancer Center Uniontown
Uniontown, Pennsylvania, 15401
UPMC Hillman Cancer Center Washington
Washington, Pennsylvania, 15301
UPMC Hillman Cancer Center Jefferson
West Mifflin, Pennsylvania, 15122
Florida Cancer Specialists
West Palm Beach, Florida, 33401
UPMC Hillman Cancer Center Williamsport
Williamsport, Pennsylvania, 17701
UPMC Memorial
York, Pennsylvania, 17408
About this study
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.
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.
Read the 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.).
- Conditions
- Primary Invasive Breast Cancer
- Being tested
- Observational
- 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
- Medical subject headings
- Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Patients with primary invasive ER+ HER2- breast cancer | 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 Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 Years
Secondary outcomes (5)
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
Measured: 10 Years
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.
Measured: 10 Years
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
Measured: 1 Year
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
Measured: 1 Year
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.
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start2 Jul 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Why it stopped: It was determined that we had sufficient enrollment and study data to explore the impact of the Endopredict test in endocrine therapy decision-making.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Invasive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 855 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Myriad Genetic Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joyce O'Shaunessey, MD, Principal investigator, US Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016935
- Sponsor's protocol ID
- ONC-010
- Status last verified
- May 2022
- First submitted
- 26 Jun 2019
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04016935
- Acronym / sponsor ID
- ONC-010
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: It was determined that we had sufficient enrollment and study data to explore the impact of the Endopredict test in endocrine therapy decision-making.
- Enrolment
- 855 participants (actual)
- Lead sponsor
- Myriad Genetic Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with primary invasive ER+ HER2- breast cancer | – | Other: ObservationalDistant 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Female
- At least 18 years of age at time of enrollment
- Able to provide informed consent
- ER+, HER2- breast tumor
- Stage T1-T3
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational | Other | Patients with primary invasive ER+ HER2- breast cancer |
Primary outcome
Evaluate DRFS of women 5-10 years post diagnosis with ER+, HER2-breast cancer who are low risk according to their EPclin scores
Time frame: 10 Years
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
5 secondary outcomes
Evaluate DRFS between years 5 and 10 post-diagnosis in women classified as low risk according to their EPclin who received extended endocrine therapy
Time frame: 10 Years
Evaluate DRFS between years 5 and 10 post-diagnosis in women classified as high risk according to their EPclin score based on treatment decisions.
Time frame: 10 Years
Evaluate adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy
Time frame: 1 Year
Evaluate adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy according to whether patients received adjuvant chemotherapy.
Time frame: 1 Year
Evaluate disease-free survival in patients stratified based on EPclin risk classification and actual treatment.
Time frame: 10 Years
Results and safety
The study was stopped early (reason given: It was determined that we had sufficient enrollment and study data to explore the impact of the Endopredict test in endocrine therapy decision-making.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce O'Shaunessey, MD principal investigator
US Oncology
52 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Invasive Breast Cancer, run by Myriad Genetic Laboratories, Inc. at 52 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: It was determined that we had sufficient enrollment and study data to explore the impact of the Endopredict test in endocrine therapy decision-making.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate DRFS of women 5-10 years post diagnosis with ER+, HER2-breast cancer who are low risk according to their EPclin scores (time frame: 10 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.