Targeting the PAM50 Her2-Enriched Phenotype With Enzalutamide in Hormone Receptor-Positive/Her2-Negative Metastatic BC — ARIANNA  

Breast Cancer Clinical Trial

Official title: Targeting the PAM50 Her2-Enriched Phenotype With Enzalutamide in Hormone Receptor-Positive/Her2-Negative Metastatic Breast Cancer

Status Terminated

Clinical Trial Summary

The main hypothesis of the study is that enzalutamide induces a significant proliferative arrest in HR+/HER2-negative breast cancer falling into the PAM50 HER2-E subtype. Currently, enzalutamide clinical development is ongoing in different prostate cancer indications but the breast cancer development program has been discontinued. As the role of the AR in HR-positive breast cancer and the predictive value of previously identified biomarker are still unclear, further research is needed to effectively utilize enzalutamide in this disease.

Clinical Trial Description

A strong rationale accumulated over the years suggests that within HR+/HER2-negative breast cancer, tumors falling into the PAM50 HER2-enriched subtype have androgen receptor (AR)-dependency. To test this hypothesis directly in patients' tumors, we propose an exploratory, open-label, non-randomized, two-cohort, multicenter, prospective, phase II study which evaluates the effect of enzalutamide on proliferation after 2 weeks (14-21 days) of treatment in patients with endocrine-resistant, locally advanced or metastatic HR+/HER2-negative breast cancer. After 2 weeks (14-21 days) of treatment, patients will continue enzalutamide. Exemestane will be allowed to be added to enzalutamide per investigator discretion and will be administered until progression or unacceptable toxicity. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT04142060
• Study type: Interventional
• Source: SOLTI Breast Cancer Research Group
• Status: Terminated
• Phase: Phase 2
• Start date: June 1, 2020
• Completion date: October 10, 2022