Epirubicin / Albumin Paclitaxel / Serplulimab · Phase 2 Trial

Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 neoadjuvant trial registration for serplulimab (a PD-L1 inhibitor) combined with epirubicin and albumin paclitaxel in early-stage HR+/HER2- breast cancer, currently recruiting. No efficacy, safety, or outcome data are available in this registry record; results have not been posted.

What was studied

Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. HR+/HER2- Breast Cancer; age from 18 Years. Intervention: Experimental: Treatment group1; Experimental: Treatment group2. Compared with: Control group — Active Comparator. n = 357. 1 site: China.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

Results from this trial, when available, may inform the role of PD-L1 inhibition combined with neoadjuvant chemotherapy in hormone receptor-positive, HER2-negative breast cancer. Currently, no efficacy or safety data exist to guide clinical practice.

Plain-language summary

Phase 2 neoadjuvant trial of an investigational PD-L1 inhibitor combined with chemotherapy in early HR+/HER2- breast cancer; no results reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: PCR rate (assessed at At the time of surgery); PCR rate in PDL1 positive subgroup (assessed at At the time of surgery)

DesignPhase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationHR+/HER2- Breast Cancer; age from 18 Years

Sample size357

InterventionExperimental: Treatment group1; Experimental: Treatment group2

ComparatorControl group — Active Comparator

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment357

PhasePHASE 2

Primary outcome measure 1PCR rate at the time of surgery

Primary outcome measure 2PCR rate in PDL1 positive subgroup at the time of surgery

Clinical bottom line

Caveats

This is a trial registration with no results posted; all findings are pending.
Randomization method, blinding status, and comparator arm structure are not described in the registry record.
Pathological complete response is a surrogate endpoint; long-term clinical outcomes (disease-free survival, overall survival) are not yet reported.
Recruitment status is RECRUITING; enrollment and follow-up are incomplete.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 interventional study; design details beyond phase not specified in registry.

Directness

moderate

Neoadjuvant setting in early HR+/HER2- breast cancer; pathological complete response is surrogate endpoint.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Registry record does not report blinding, randomization method, or comparator arm structure.

Sample adequacy

moderate

Planned enrollment 357 participants; adequate for Phase 2 but not yet recruited or analysed.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06860529). This is a study registration, not published results. Lead sponsor: Henan Cancer Hospital. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 357 participants (ESTIMATED). Conditions: HR+/HER2- Breast Cancer. Interventions: DRUG: Serplulimab; DRUG: Epirubicin; DRUG: Albumin Paclitaxel. Primary outcome measures: PCR rate , At the time of surgery; PCR rate in PDL1 positive subgroup , At the time of surgery. Brief summary: The neoadjuvant treatment options commonly used for HR+/HER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice. The aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HR+/HER2- breast cancer

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

EpirubicinAlbumin PaclitaxelHenan Cancer HospitalNCT06860529SerplulimabHR+/HER2 Breast Cancer