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ASCO 2026 | HELEN-Trio 011: camrelizumab plus chemotherapy as neoadjuvant therapy in TNBC

Shipra Gandhi, MD, MS, Emory University, Atlanta, GA, discusses efficacy and safety findings from the HELEN-Trio 011 trial (NCT05475678) of neoadjuvant camrelizumab with docetaxel and carboplatin in patients with previously untreated stage II–III triple-negative breast cancer (TNBC). Results demonstrated a significantly improved pathologic complete response rate with the addition of camrelizumab versus chemotherapy alone, with a manageable safety profile, supporting this anthracycline-free regimen as a promising neoadjuvant option in early TNBC. This interview took place during the 2026 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.

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Transcript

So the HELEN-Trio 011 was a randomized controlled trial that tested the addition of camrelizumab with carboplatin and docetaxel versus carboplatin and docetaxel in early stage triple negative breast cancer. The study showed an improvement in pathologic complete response with the addition of camrelizumab, which was statistically significant. Importantly, they showed that this was preferentially beneficial in the PD-L1 positive population, and the side effect profile was favorable...

So the HELEN-Trio 011 was a randomized controlled trial that tested the addition of camrelizumab with carboplatin and docetaxel versus carboplatin and docetaxel in early stage triple negative breast cancer. The study showed an improvement in pathologic complete response with the addition of camrelizumab, which was statistically significant. Importantly, they showed that this was preferentially beneficial in the PD-L1 positive population, and the side effect profile was favorable. Their IRAE was 2.1%, which was significantly less than what we have seen in other trials with an anthracycline-containing regimen.

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