OPERA: a phase II study of DHP107 (oral paclitaxel) versus intravenous paclitaxel in patients with HER2-negative recurrent or metastatic breast cancer.

PURPOSE

DHP107 is an oral paclitaxel enabling administration of paclitaxel without Cremophor EL, a vehicle used to improve the solubility of intravenous (IV) paclitaxel. The randomized phase II OPERA study investigated the efficacy and safety of DHP107 versus IV paclitaxel in patients with HER2-negative breast cancer.

METHODS

OPERA was conducted in the USA and Czech Republic. Patients were ≥ 18 years, with measurable disease, and histologically or cytologically confirmed recurrent or metastatic breast cancer with any tumor hormone receptor status. Patients were randomized 2:1 to DHP107 (200 mg/m² po bid with premedication if needed on days 1, 8, and 15, every 28 days) or IV paclitaxel (80 mg/m² with standard premedication on days 1, 8, and 15 every 28 days). The primary objective was DHP107 efficacy; secondary objectives included DHP107 safety and tolerability.

RESULTS

72 patients were randomized, 48 to DHP107 and 24 to IV paclitaxel. There was one complete response and 11 partial responses with DHP107 (objective response rate [ORR 25.0%; 90% CI 15.1-37.3), and six partial responses with IV paclitaxel (objective response rate [ORR] 28.6%; 90% CI 13.2-48.7; p = 0.7559). Median progression-free survival (PFS) was 5.5 months for DHP107 and 4.7 months for IV paclitaxel (p = 0.8018); median overall survival (OS) was 17.1 and 13.2 months, respectively (p = 0.7629). Common all-grade adverse events were diarrhea (68.8%), nausea (64.6%), and fatigue (52.1%) for DHP107 and fatigue (47.6%), peripheral neuropathy (42.9%), and alopecia (42.9%) for IV paclitaxel.

CONCLUSION

DHP107 is a tolerable and feasible treatment for patients with recurrent or metastatic HER2-negative breast cancer, with similar efficacy and safety to IV paclitaxel.

CLINICALTRIALS

gov no: NCT03326102; date of registration October 19, 2017.

© 2026. The Author(s).