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)

Launched by SHANGHAI HENLIUS BIOTECH · Mar 9, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HLX10, which is being tested alongside standard chemotherapy for women with triple-negative breast cancer (TNBC) that has not spread to other parts of the body. The goal is to see if adding HLX10 can improve treatment outcomes compared to a placebo (which looks like the treatment but has no effect) when given before surgery and then after surgery. Women who are between the ages of 18 and 75, have not been treated for this type of cancer before, and meet certain health criteria may be eligible to participate.

Participants in the trial will be randomly assigned to one of two groups: one will receive HLX10 with chemotherapy, while the other will receive a placebo with chemotherapy. Both groups will go through several cycles of chemotherapy before having surgery and then continue with either HLX10 or placebo for additional treatments. Throughout the study, participants will be closely monitored for any side effects and how well the treatment is working. It's important for potential participants to understand that they must use contraception during the study and have good overall health to be eligible.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. 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).
• 2. Subjects who are judged as one of the following by the American Joint Committee on Cancer (AJCC) within 4 weeks prior to randomisation:
• • 1. T1c, N1-N2, M0
• • 2. T2, N0-N2, M0
• • 3. T3, N0-N2, M0
• • 4. T4a-c, N0-N2, M0.
• • 3. Major organs are functioning well
• • 4. Participant must keep contraception
• Exclusion Criteria:
• • 1. 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.
• • 2. Subjects who have received chemotherapy, targeted therapy, or radiotherapy within 12 months prior to the initial dose of the investigational product.
• • 3. Subjects with a history of severe allergy to any monoclonal antibody or investigational product and its excipient.
• • 4. Pregnant or lactating women.
• • 5. Subjects with a known history of psychotropics abuse or drug abuse
• • 6. Subjects presenting other factors not suitable for participation as judged by the investigator.