Pyrotinib Plus Neoadjuvant Chemotherapy in HR+/HER2-, HER4-High Breast Cancer
Summary
This is a Phase II, single-center, double-blind, placebo-controlled, randomized study of Pyrotinib in combination with Doxorubicin/Epirubicin and Cyclophosphamide followed by Docetaxel/nab-Paclitaxel as neoadjuvant therapy for women with hormone receptor positive HER2-negative stage II to III breast cancer. Patients randomized to the study arm/control arm will receive standard neoadjuvant chemotherapy in combination with pyrotinib/placebo, respectively. The primary endpoint of the study is the residual cancer burden 0/I (RCB 0/I) and total pathological complete response (tpCR) rate. Secondary endpoints include the breast pCR (bpCR) rate, objective response rate(ORR), event-free survival (EFS), overall survival (OS), rate of change in the Ki-67 proliferation index, correlations between potential biomarkers and treatment efficacy, and toxicity.
Timeline
- Start
- 2021-04-20
- Primary completion
- 2026-02-27
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pyrotinib | Small molecule | 400 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Background | Docetaxel | Small molecule | 100 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 30 mg/m2 | Intravenous |
| Background | Epirubicin | Small molecule | 100 mg/m2 | Intravenous |
| Background | Nab-paclitaxel | Small molecule | 120 mg/m2 | — |
| Background | Nab-paclitaxel | Small molecule | 260 mg/m2 | — |