drugset / Trial / NCT03176238

Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

NCT03176238

Phase 3 Completed 235 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

This international, multi-center, open-label, single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitors (NSAI) therapy in Novartis Oncology emergent growth market (EGM) countries.Data was presented by Asian countries vs Non-Asian countries to confirm no difference in safety and efficacy. Summary statistics were presented.

Timeline

Start
2013-03-29
Primary completion
2019-01-29
Completion
2019-01-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 10 mg Oral
Background Exemestane Small molecule 25 mg Oral

Indications