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Clinical trial

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)

NCT04301739 is registered in ClinicalTrials.gov with Shanghai Henlius Biotech as lead sponsor.

NCT NCT04301739
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Registry record

As filed in ClinicalTrials.gov.

Title
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)
Lead sponsor
Shanghai Henlius Biotech
Phase
Phase 3
Overall status
Not yet recruiting
Start date
April 17, 2020
Completion date
April 9, 2027
Enrollment
522 (estimated)
Sites
Not reported

Conditions

As the registry lists them; a condition with its own page is linked.

triple negative breast cancer