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)

NCT04301739 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: HLX10-013-TNBCneo
• Study Type: interventional
• Target: 522
• Locations: 0 countries
• Sites: N/A

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

Keywords

Triple Negative Breast Cancer; Previously Untreated; Potentially Resectable; Without Distant Metastasis

Outcome Measures

Primary Outcomes (1)

• 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)

  up till 5 years after the enroll

Study Arms (2)

HLX10 + chemotherapy→ HLX10

EXPERIMENTAL

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

Drug: HLX10; Drug: nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide

Placebo + chemotherapy→ Placebo

PLACEBO COMPARATOR

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

Drug: nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide; Drug: Placebo

Interventions

HLX10 DRUG

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

HLX10 + chemotherapy→ HLX10

nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide DRUG

chemotherapeutics

HLX10 + chemotherapy→ HLX10; Placebo + chemotherapy→ Placebo

Placebo DRUG

Placebo

Placebo + chemotherapy→ Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Carboplatin; Doxorubicin; Epirubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Tieshuang Chi, Master

CONTACT

+8618621117100; olivia_chi@henlius.com.cn

Weizhen Liu, Bachelor

CONTACT

+8618801610708; weizhen_liu@henlius.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: April 17, 2020
• Primary Completion: September 7, 2022
• Study Completion (Estimated): April 9, 2027
• Last Updated: March 12, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share