Phase 3 Study of Everolimus Plus Chemotherapy Versus Chemotherapy Alone for First-Line Treatment of Inoperable or Metastatic Triple-Negative Breast Cancer with Luminal Androgen Receptor Subtype and PAM Pathway Mutation

What this Trial Is About

This trial studies women with locally recurrent inoperable or metastatic triple-negative breast cancer TNBC of the luminal androgen receptor LAR subtype with a specific mutation in the PI3KAKTmTOR PAM pathway. It evaluates whether combining everolimus with an investigators choice of chemotherapy improves outcomes as a first-line treatment, compared to chemotherapy alone. The study also assesses the impact on patients quality of life. Participants will be randomly assigned to receive either everolimus plus one of several chemotherapy options nab-paclitaxel, capecitabine, eribulin, carboplatin, vinorelbine, or utidelone or chemotherapy alone. Treatment is given under medical supervision and aims to compare progression-free survival and overall survival between these groups. This is an open-label, phase III study. During approximately three years, participants will undergo regular scans CTMRI to evaluate tumor response and progression. Researchers will monitor survival, treatment safety, side effects, and patient-reported outcomes related to quality of life. Organ function and laboratory tests will be checked to ensure participant safety and treatment tolerance throughout the study.

Everolimus With Investigator's Choice of Chemotherapy in Advanced Triple-Negative Breast Cancer (TNBC) With Luminal Androgen Receptor (LAR) Subtype