# to Evaluate Efficacy and Safety of HLX10 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versu

Source: https://onco.cc/trials/nct04301739/  
OnCo record `nct04301739` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of serplulimab, nab-paclitaxel, carboplatin, doxorubicin and other drugs in triple-negative breast cancer, run by Shanghai Henlius Biotech, not yet recruiting.

## Summary

to Evaluate Efficacy and Safety of HLX10 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versus Placebo as Adjuvant Therapy in Patients With Triple Negative Breast Cancer (TNBC) is a phase 3, randomised interventional study registered as NCT04301739 by Shanghai Henlius Biotech, with a registry enrolment figure of 522 participants, started 2020-04-17 and due to reach its primary completion in 2022-09-07. Interventions recorded: HLX10; nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide; Placebo. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: "Subjects histologically diagnosed with previously untreated TNBC (lack of human epidermal growth factor receptor-2 \[HER2\], estrogen receptor \[ER\], progesterone receptor expression as determined by the study site)". No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: planned
- Last checked: 2026-09-24
- Tags: ctgov-ingest; tnbc-deep-dive
- Registry id: NCT04301739
- Phase: 3
- Setting: A Randomized, Double-Blind, International Multi-Centre, Phase III Clinical Study to Evaluate Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versus Placebo as Adjuvant Therapy in Patients With Triple Negative Breast Cancer (TNBC)
- Sponsor: Shanghai Henlius Biotech
- Enrolled: 522

## Sources

- ClinicalTrials.gov NCT04301739: https://clinicaltrials.gov/study/NCT04301739

## Connected records

- cancers: [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [Platinum agents](https://onco.cc/technologies/platinum/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Cyclophosphamide](https://onco.cc/drugs/cyclophosphamide/), [Doxorubicin](https://onco.cc/drugs/doxorubicin/), [Epirubicin](https://onco.cc/drugs/epirubicin/), [Nab-paclitaxel](https://onco.cc/drugs/nab-paclitaxel/), [Serplulimab](https://onco.cc/drugs/serplulimab/)
- terms: [Triple-negative breast cancer trials open today (registry snapshot and UK sites)](https://onco.cc/terms/tnbc-trials-open-today/)

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