425RO A randomized phase II study of pembrolizumab plus carboplatin vs. carboplatin alone in unresectable advanced breast cancer (ABC) with chest wall disease (CWD) [ICI-CHEST, TBCRC 44]

May 1, 2026ESMO OpenOpen Access

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Key Points

Evaluate the effects of pembrolizumab combined with carboplatin versus carboplatin alone in patients with unresectable advanced breast cancer.
Randomized phase II trial comparing pembrolizumab plus carboplatin to carboplatin only.
Inclusion of patients with unresectable advanced breast cancer and chest wall disease.
Assessments adjusted for potential confounders.
In patients with PD-L1+ tumors, an increase in median progression-free survival (mPFS) by 4.1 months was observed favoring the combination therapy.
The median overall survival (mOS) increased by 6.6 months in patients receiving the combination, although results were non-significant.
Overall, the addition of pembrolizumab did not significantly improve outcomes in HR+/HER2-MBC unselected by PD-L1.

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Randomized trial evaluates combination therapy for improved outcomes in unresectable advanced breast cancer, suggesting further research is needed.

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Vidula et al. (2026) studied this question.

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