drugset / Trial / NCT03176238
Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 10 mg | Oral |
| Background | Exemestane | Small molecule | 25 mg | Oral |