drugset / Trial / NCT05189067
Efficacy and Safety of Adjuvant Docetaxel and Trastuzumab in Stage I HER2-positive Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
Among women with stage I HER2-positive breast cancer, adjuvant weekly paclitaxel plus trastuzumab (PH, qw×12) is one of the standard therapies. However, it is quite inconvenient for patients to received weekly treatment for 12 weeks, which also increased the patients' and social economic burdens. In our study, a prospective, randomized, open-label, single-center clinical study was conducted to compare the efficacy and safety of adjuvant docetaxel plus trastuzumab (TH, q3w×4) and the classic regimen (PH, qw×12) in stage I HER2-positive breast cancer in Chinese population.
Timeline
- Start
- 2022-01-31
- Primary completion
- 2025-01-31
- Completion
- 2025-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |