A phase 2 interventional trial at Henan Cancer Hospital is actively recruiting to assess the efficacy and safety of the anti-PD-1 antibody serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant setting for early-stage HR+/HER2− breast cancer. The study addresses a gap in immunotherapy integration within this historically chemotherapy-dependent subtype.
A phase 2 interventional trial (NCT06860529) is currently recruiting participants at Henan Cancer Hospital to investigate serplulimab—a PD-1 checkpoint inhibitor—in combination with nab-paclitaxel and epirubicin as neoadjuvant therapy for early-stage hormone receptor-positive, HER2-negative breast cancer.
HR+/HER2− breast cancer has traditionally relied on anthracycline- and taxane-based neoadjuvant regimens, with nab-paclitaxel increasingly preferred over solvent-based paclitaxel due to demonstrated superiority in efficacy outcomes. The combination of nab-paclitaxel with epirubicin has consequently gained traction in clinical practice. This trial seeks to determine whether the addition of serplulimab to this established backbone can meaningfully improve pathologic response rates in this subtype, which has shown comparatively modest benefit from neoadjuvant immunotherapy relative to triple-negative breast cancer.
The rationale for exploring PD-1 inhibition in HR+/HER2− disease stems from emerging evidence that a subset of these tumors harbors an immunologically active microenvironment that may be amenable to checkpoint blockade. Serplulimab, already approved in certain indications in China, is being evaluated here for its potential to augment chemotherapy-induced antitumor immunity in the preoperative context. Primary endpoints and full eligibility criteria have not been detailed in the available registration data.
Key points
- Phase 2 trial (NCT06860529) is actively recruiting at Henan Cancer Hospital to evaluate serplulimab with nab-paclitaxel and epirubicin as neoadjuvant therapy in early-stage HR+/HER2− breast cancer.
- Serplulimab is a PD-1 checkpoint inhibitor being tested in a subtype where immunotherapy benefit has been less established than in triple-negative disease.
- Nab-paclitaxel plus epirubicin serves as the chemotherapy backbone, reflecting current clinical preference for albumin-bound paclitaxel over solvent-based formulations.
- The trial aims to characterize both efficacy and safety of this combination in the neoadjuvant setting.
- Detailed eligibility criteria and primary endpoints are not fully disclosed in the available trial registration data.
Why it matters
HR+/HER2− breast cancer represents the largest breast cancer subtype, yet neoadjuvant pathologic complete response rates remain low with chemotherapy alone. Defining whether PD-1 inhibition with serplulimab can improve preoperative outcomes in this population could influence future treatment algorithms for early-stage disease.