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)

Phase 3

Not yet recruiting

• Conditions: Triple Negative Breast Cancer
• Interventions: Drug: HLX10; Drug: Placebo; Drug: nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide

• Registration Number: NCT04301739
• Lead Sponsor: Shanghai Henlius Biotech

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-10
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12
• Study Start: 2020-04-17
• Primary Completion: 2022-09-07
• Study Completion: 2027-04-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 522

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HLX10 + chemotherapy→ HLX10	HLX10	HLX10 + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → HLX10 + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → HLX10 (9 cycles)
Placebo + chemotherapy→ Placebo	Placebo	Placebo + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → Placebo + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → Placebo (9 cycles)
HLX10 + chemotherapy→ HLX10	nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide	HLX10 + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → HLX10 + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → HLX10 (9 cycles)
Placebo + chemotherapy→ Placebo	nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide	Placebo + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → Placebo + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → Placebo (9 cycles)

Primary Outcome Measures

Name	Time	Method
tumor assessment	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)