drugset / Trial / NCT04337658
Anti-HER2 Therapy + Fulvestrant/Capecitabine in Women With HR+, HER2+, Non-visceral Metastases Stage IV Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the effectiveness of anti-HER2 therapy plus Fulvestrant or Capecitabine in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+), non-visceral metastases, stage IV breast cancer.
Timeline
- Start
- 2020-07-01
- Primary completion
- 2024-04-30
- Completion
- 2026-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Background | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |