- 5-year follow-up of a phase 2 trial continues to support the safety and efficacy of weekly paclitaxel with trastuzumab and pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (mBCa).
Why this matters
- Combination has been endorsed as front-line combination therapy by the National Comprehensive Cancer Network.
- Single-arm phase 2 trial of adults with HER2+ mBCa (n=69) who received either no prior therapy (74%) or 1 prior therapy (26%).
- Dosing: intravenous paclitaxel (80 mg/m2 weekly) with trastuzumab (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) and pertuzumab (840 mg loading dose followed by 420 mg every 3 weeks), given in 21-day cycles.
- Funding: Roche-Genentech.
- Median follow-up, 59 months.
- 6-month PFS, 86% (95% CI, 76%-93%).
- Median PFS was 24.2 months (95% CI, 17-35) overall.
- 25.7 months (95% CI, 17-not reached) for the no prior therapy group.
- 20.1 months (95% CI, 8.5-33.0) for the 1 prior therapy group.
- Median OS was not reached overall.
- Not reached for the no prior therapy group.
- 39.7 months (95% CI, 32.9-66.7) for the 1 prior therapy group.
- No new safety concerns emerged.
- Small sample.
- No randomization.