Clinical Trials Logo
  1. Home
  2. Triple Negative Breast Cancer
  3. 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)

Triple Negative Breast Cancer Clinical Trial

Official 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)

Clinical Trial Summary

This study is a randomized, double-Blind,international multi-Centre, phase III clinical study 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 previously untreated and potentially resectable patients with TNBC and without distant metastasis.

Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:

Arm A (HLX10 arm): HLX10 + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → HLX10 + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → HLX10 (9 cycles) Arm B (placebo arm): Placebo + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → Placebo + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → Placebo (9 cycles) The three stratification factors for randomization include: lymph node metastasis (yes or no), size of primary tumor lesion (T1/T2 or T3/T4), asian population (yes or no).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04301739
Study type Interventional
Source Shanghai Henlius Biotech
Contact Tieshuang Chi, Master
Phone +8618621117100
Email olivia_chi@henlius.com.cn
Status Not yet recruiting
Phase Phase 3
Start date April 17, 2020
Completion date April 9, 2027
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05174832 - Induction of Cisplatin/Nab-paclitaxel/Pembrolizumab Followed by Olaparib/Pembrolizumab Maintenance in mTNBC Patients Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Withdrawn NCT03634150 - Safety and Efficacy of IV Nerofe™ Followed by Doxorubicin, In Metastatic Ovarian Cancer and Triple Negative Breast Cancer Phase 1/Phase 2
Recruiting NCT03348098 - Clinical Study of Neoadjuvant Therapy With Apatinib and Paclitaxel in Local Advanced Triple-negative Breast Cancer Phase 2
Completed NCT04032080 - LY3023414 and Prexasertib in Metastatic Triple-negative Breast Cancer Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Withdrawn NCT02427581 - Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy Phase 1
Recruiting NCT03165487 - Comparison of the Breast Tumor Microenvironment
Completed NCT02225470 - Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes Phase 3
Recruiting NCT04452370 - Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer Phase 2
Terminated NCT04123704 - Sitravatinib in Metastatic Breast Cancer Phase 2
Recruiting NCT04758780 - Imaging Performance Assessment of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT in Metastatic Triple Negative Breast Cancer Patients Phase 2
Withdrawn NCT04268693 - Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer
Withdrawn NCT03982173 - Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors Phase 2
Not yet recruiting NCT02685657 - Neoadjuvant Chemotherapy Docetaxel With or Without SELUMETINIB in Patients With Triple Negative Breast Cancer Phase 2
Terminated NCT01918306 - GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer Phase 1/Phase 2
Completed NCT01276899 - Study to Identify Molecular Mechanisms of Clinical Resistance to Chemotherapy in Triple Negative Breast Cancer Patients
Completed NCT00998036 - Study of Temsirolimus, Erlotinib and Cisplatin in Solid Tumors Phase 1
Recruiting NCT05309655 - Cardiac Outcomes With Near-Complete Estrogen Deprivation Early Phase 1
Active, not recruiting NCT03267316 - A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors Phase 1/Phase 2