EndoPredict® Extended Endocrine Trial (EXET)

Launched by MYRIAD GENETIC LABORATORIES, INC. · Jul 9, 2019

Keywords

ClinConnect Summary

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 ...

Gender

FEMALE

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