Primary Invasive Breast Cancer
Conditions
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
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.).
Interventions
OTHERObservational
Observational
Sponsors
Myriad Genetic Laboratories, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate DRFS of women 5-10 years post diagnosis with ER+, HER2-breast cancer who are low risk according to their EPclin scores | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 high risk according to their EPclin score based on treatment decisions. | 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 adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy | 1 Year | 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 |
| Evaluate adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy according to whether patients received adjuvant chemotherapy. | 1 Year | 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 |
| Evaluate disease-free survival in patients stratified based on EPclin risk classification and actual treatment. | 10 Years | Evaluate disease-free survival in patients stratified based on EPclin risk classification and actual treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Compare previous chemotherapy treatment decisions to chemotherapy treatment recommendations based on EndoPredict® risk classification. | 1 Year | Compare previous chemotherapy treatment decisions to chemotherapy treatment recommendations based on EndoPredict® risk classification. |
| Repeat all primary and secondary objectives in subsets of patients based on variables such as clinicopathologic features and treatment. | 10 Years | Repeat all primary and secondary objectives in subsets of patients based on variables such as clinicopathologic features and treatment. |
Countries
United States
Outcome results
None listed