Breast cancer (Tokyo, Japan) · 2026
A phase II study combining radiotherapy and atezolizumab/nab-paclitaxel for inoperable or recurrent programmed death-ligand 1-positive triple-negative breast cancer: IMRad-Br study protocol and safety run-in.
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Ishiguro Hiroshi, Hoshi Nobuhiro, Noda Shin-Ei, Tokuda Emi, Nukui Asami, Yoshimoto Yuya, Takahashi Fumiaki, Saji Shigehira, Kato Shingo, Ohtake Tohru, Osaki Akihiko, Suzuki Yoshiyuki
Аннотация
BACKGROUND: Triple-negative breast cancer (TNBC) is an aggressive subtype lacking estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 expressions, with poor prognosis and limited treatment options. Studies have demonstrated the efficacy of immune checkpoint inhibitors (ICIs) combined with chemotherapy in patients with programmed death-ligand 1 (PD-L1)-positive advanced TNBC. Radiotherapy (RT) may enhance therapeutic effects when combined with ICIs.
METHODS: In this ongoing single-arm, multicenter phase II trial (IMRad-Br; jRCTs021210010), we aimed to evaluate the safety and feasibility of combining atezolizumab/nab-paclitaxel with local RT in patients with inoperable or recurrent PD-L1-positive TNBC. Patients received atezolizumab (840 mg on days 1 and 15 of a 28-day cycle) and nab-paclitaxel (100 mg/m2 on days 1, 8, and 15), followed by local RT at 30 Gy in five fractions. A safety run-in was conducted in six evaluable patients to assess protocol-defined prespecified adverse events of interest (PAEIs).
RESULTS: Among the seven patients enrolled, one PAEI was observed (grade 4 liver injury), which improved with treatment interruption and follow-up. Two additional serious adverse events occurred but were unrelated to the study treatment. No unexpected toxicity was observed. Combination therapy was deemed feasible by an Independent Data Monitoring Committee.
CONCLUSION: The combination of atezolizumab/nab-paclitaxel with local RT was feasible and did not result in unexpected toxicities during the safety run-in phase. This study is ongoing to evaluate the safety and therapeutic potential of ICI-RT combination therapy for recurrent PD-L1-positive TNBC. The final analysis will determine whether this approach merits broader clinical adoption.
METHODS: In this ongoing single-arm, multicenter phase II trial (IMRad-Br; jRCTs021210010), we aimed to evaluate the safety and feasibility of combining atezolizumab/nab-paclitaxel with local RT in patients with inoperable or recurrent PD-L1-positive TNBC. Patients received atezolizumab (840 mg on days 1 and 15 of a 28-day cycle) and nab-paclitaxel (100 mg/m2 on days 1, 8, and 15), followed by local RT at 30 Gy in five fractions. A safety run-in was conducted in six evaluable patients to assess protocol-defined prespecified adverse events of interest (PAEIs).
RESULTS: Among the seven patients enrolled, one PAEI was observed (grade 4 liver injury), which improved with treatment interruption and follow-up. Two additional serious adverse events occurred but were unrelated to the study treatment. No unexpected toxicity was observed. Combination therapy was deemed feasible by an Independent Data Monitoring Committee.
CONCLUSION: The combination of atezolizumab/nab-paclitaxel with local RT was feasible and did not result in unexpected toxicities during the safety run-in phase. This study is ongoing to evaluate the safety and therapeutic potential of ICI-RT combination therapy for recurrent PD-L1-positive TNBC. The final analysis will determine whether this approach merits broader clinical adoption.