Pyrotinib plus nab-paclitaxel as adjuvant therapy for patients with N0/N1mi, HER2-positive early-stage breast cancer: 3-year iDFS results of the phase II PHAEDRA trial.
Randomized trial evaluates 3-year invasive disease-free survival in women with low-risk, HER2-positive early-stage breast cancer, indicating potential for treatment de-escalation.
Key Points
This study aims to evaluate the efficacy and safety of adjuvant pyrotinib combined with nab-paclitaxel in patients with low-risk, HER2-positive early-stage breast cancer.
Multicenter, single-arm, phase II trial enrolling 263 women aged 18-75 with HER2-positive early-stage breast cancer.
Patients received nab-paclitaxel followed by pyrotinib for a total of 12 weeks plus 1 year of monotherapy.
Primary endpoint was invasive disease-free survival (iDFS).
The estimated 3-year iDFS rate was 96.8% (95% CI 93.4-98.5).
Nine iDFS events occurred in the cohort (3.4%).
Common grade ≥3 treatment-related adverse events included diarrhea (50.6%) and neutropenia (14.4%).