- In a phase 2 trial, bevacizumab added on to liposomal doxorubicin, cyclophosphamide, and paclitaxel is safe and effective for treating premenopausal women with grade 3 locally advanced breast cancer (LABC; tumor size >3 cm) that is human epidermal growth factor receptor 2 (HER2)-negative, hormone receptor (HR)-positive, or triple-negative breast cancer (TNBC) subtype.
Why this matters
- Progression to phase 3 trial is warranted.
- 62 patients were given intravenous liposomal doxorubicin 30 mg/m2, cyclophosphamide 600 mg/m2, paclitaxel 120 mg/m2, and bevacizumab 8 mg/kg on day 1 of 15-day cycles for 4 cycles.
- Primary outcomes were clinical complete response (cCR) and pathologic complete response (pCR).
- Patients were followed for 3 years.
- Funding: None.
- 32.3% of patients were hormone-receptor positive (HR+), 67.7% were TNBC, and all received surgery.
- cCR was 25.8%.
- pCR was 38.7%:
- For TNBC patients pCR was 42.9%;
- For HR+ patients pCR was 30%.
- DFS was 87.1%.
- Hematologic adverse events (AEs) included neutropenia (74.2% across all grades; 22.6% grade [G] 3) and febrile neutropenia (6.5% G3).
- Nonhematologic AEs G3 included nausea (6.5%), mucositis (9.7%), and grade 1/2 infection (3.2%), all managed effectively.
- Small sample size.
- No control group.