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March 30, 2026Breast Cancer Research and TreatmentOpen Access

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

Hope S. Rugo T. J. Pluard P. Sharma M. Melisko G. Al-Jazayrly Yan Ji Neelima Vidula John R. Ellerton Martin Šmakal Martina Zimovjanová David Weng

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Key Points

This study aims to evaluate the effectiveness of DHP107 (oral paclitaxel) compared to intravenous paclitaxel in treating HER2-negative recurrent or metastatic breast cancer.
Conducted as a phase II clinical study
Compared oral DHP107 with intravenous paclitaxel
Targeted patients with HER2-negative breast cancer
Analyzed efficacy and safety outcomes
Preliminary findings indicated potential effectiveness of oral paclitaxel
Safety profiles were comparable between the two treatment options
Patients experienced various responses to both treatments

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Implication

Phase II study compares oral paclitaxel to intravenous paclitaxel in HER2-negative breast cancer, suggesting effective treatment options.

Abstract

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

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Cite This Study

Rugo et al. (2026) studied this question.

synapsesocial.com/papers/69ccb7b016edfba7beb89c6d https://doi.org/10.1007/s10549-026-07944-2

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Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

1OPTIMAL: A Multinational Phase III Study of Oral Paclitaxel (DHP107) versus Intravenous Weekly Paclitaxel in HER2-Negative Recurrent or Metastatic Breast CancerLate-Phase Clinical Trial · 2026
2A randomized, open-label, two-way crossover clinical trial to evaluate the food effect on pharmacokinetics and safety of DHP107 in patients with advanced solid tumors: the FEEL studyHuman Clinical Trial · 2026
3Paclitaxel liposome with anti–HER-2 drugs as first-line therapy for recurrent/metastatic HER-2–positive breast cancer: a real-world studyOriginal Research · 2026
4Abstract PO1-27-05: De-escalated neoadjuvant weekly nab-paclitaxel with trastuzumab and pertuzumab in HER2-positive early breast cancer (HELEN-006):a randomized,phase 3 trial2024
5Neoadjuvant Taxane Plus Trastuzumab and Pertuzumab With or Without Carboplatin in Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: The Randomized Noninferiority Phase III neoCARHP TrialLate-Phase Clinical Trial · 2026 · 15 citations

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