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NCT Number: 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)

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).

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Subjects who are judged as one of the following by the American Joint Committee on Cancer (AJCC) within 4 weeks prior to randomisation:
  • T1c, N1-N2, M0
  • T2, N0-N2, M0
  • T3, N0-N2, M0
  • T4a-c, N0-N2, M0.
  • Major organs are functioning well
  • Participant must keep contraception

Exclusion criteria

  • Subjects with any other active malignancy within 5 years prior to signing the informed consent form or at the same time. Localised tumours that have been cured such as basal cell carcinoma, squamous-cell skin cancer, superficial bladder carcinoma, and cervical cancer in situ are acceptable.
  • Subjects who have received chemotherapy, targeted therapy, or radiotherapy within 12 months prior to the initial dose of the investigational product.
  • Subjects with a history of severe allergy to any monoclonal antibody or investigational product and its excipient.
  • Pregnant or lactating women.
  • Subjects with a known history of psychotropics abuse or drug abuse
  • Subjects presenting other factors not suitable for participation as judged by the investigator.

Treatment and study plan

HLX10

Drug

HLX10 is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc.

nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide

Drug

chemotherapeutics

Placebo

Drug

Placebo

Primary outcomes

  1. tumor assessment

    Time frame: up till 5 years after the enroll

    Pathological complete response (pCR) rate (ypT0/Tis, ypN0) (assessed by central pathology laboratory based on American Joint Committee on Cancer (AJCC) staging system)

Study contacts

Contact information is provided by the study sponsor or research team.

Tieshuang Chi, Master

CONTACT

[email protected]

+8618621117100

Weizhen Liu, Bachelor

CONTACT

[email protected]

+8618801610708

Sponsors and collaborators

Lead sponsor

Shanghai Henlius Biotech

Industry

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2022
Study completion
2027
First posted
Mar 10, 2020
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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