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)

NCT ID: NCT04301739

Last Updated: 2020-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 522 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-17
• Study Completion Date: 2027-04-09

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).

Conditions

Triple Negative Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HLX10 + chemotherapy→ HLX10

HLX10 + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → HLX10 + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → HLX10 (9 cycles)

Group Type: EXPERIMENTAL

HLX10

Intervention Type: DRUG

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

nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide

Intervention Type: DRUG

chemotherapeutics

Placebo + chemotherapy→ Placebo

Placebo + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → Placebo + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → Placebo (9 cycles)

Group Type: PLACEBO_COMPARATOR

nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide

Intervention Type: DRUG

chemotherapeutics

Placebo

Intervention Type: DRUG

Placebo

Interventions

HLX10

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

Intervention Type: DRUG

nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide

chemotherapeutics

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Tieshuang Chi, Master

Role: CONTACT

olivia_chi@henlius.com.cn

+8618621117100

Weizhen Liu, Bachelor

Role: CONTACT

weizhen_liu@henlius.com.cn

+8618801610708

Other Identifiers

HLX10-013-TNBCneo

Identifier Type: -

Identifier Source: org_study_id