deltatrials
Not Yet Recruiting PHASE3 INTERVENTIONAL 2-arm NCT04301739

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)

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

Updated 4 times since 2020 Last updated: Mar 10, 2020 Started: Apr 17, 2020 Primary completion: Sep 7, 2022 Completion: Apr 9, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Triple Negative Breast Cancer and is currently actively recruiting participants. Shanghai Henlius Biotech leads this study, which shows 4 recorded versions since 2020 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Apr 2020 – ~Jan 2021 · 9 months · monthly snapshotNot Yet Recruiting~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotNot Yet Recruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 24 months · monthly snapshotNot Yet Recruiting

Change History

4 versions recorded
  1. Sep 2024 — Present [monthly]

    Not Yet Recruiting PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Not Yet Recruiting PHASE3

  3. Jan 2021 — Jul 2024 [monthly]

    Not Yet Recruiting PHASE3

  4. Apr 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Shanghai Henlius Biotech
Data source: Shanghai Henlius Biotech

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.