Back to resultsto 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)
Primary Purpose
Triple Negative Breast Cancer
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
HLX10
nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Triple Negative Breast Cancer, Previously Untreated, Potentially Resectable, Without Distant Metastasis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HLX10 + chemotherapy→ HLX10
Placebo + chemotherapy→ Placebo
Arm Description
HLX10 + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → HLX10 + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → HLX10 (9 cycles)
Placebo + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → Placebo + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → Placebo (9 cycles)
Outcomes
Primary Outcome Measures
tumor assessment
Pathological complete response (pCR) rate (ypT0/Tis, ypN0) (assessed by central pathology laboratory based on American Joint Committee on Cancer (AJCC) staging system)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04301739
Brief Title
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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 17, 2020 (Anticipated)
Primary Completion Date
September 7, 2022 (Anticipated)
Study Completion Date
April 9, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Henlius Biotech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer
Keywords
Triple Negative Breast Cancer, Previously Untreated, Potentially Resectable, Without Distant Metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
522 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HLX10 + chemotherapy→ HLX10
Arm Type
Experimental
Arm Description
HLX10 + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → HLX10 + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → HLX10 (9 cycles)
Arm Title
Placebo + chemotherapy→ Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → Placebo + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → Placebo (9 cycles)
Intervention Type
Drug
Intervention Name(s)
HLX10
Intervention Description
HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide
Intervention Description
chemotherapeutics
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
tumor assessment
Description
Pathological complete response (pCR) rate (ypT0/Tis, ypN0) (assessed by central pathology laboratory based on American Joint Committee on Cancer (AJCC) staging system)
Time Frame
up till 5 years after the enroll
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tieshuang Chi, Master
Phone
+8618621117100
Email
olivia_chi@henlius.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Weizhen Liu, Bachelor
Phone
+8618801610708
Email
weizhen_liu@henlius.com.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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)
We'll reach out to this number within 24 hrs