Status:
NOT_YET_RECRUITING
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)
Lead Sponsor:
Shanghai Henlius Biotech
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief 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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 9 2027
Estimated Enrollment :
522 Patients enrolled
Trial Details
Trial ID
NCT04301739
Start Date
April 17 2020
End Date
April 9 2027
Last Update
March 12 2020
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