Inetetamab Combined With Anti-PD-1 Monoclonal Antibody and Albumin-Bound Paclitaxel for HER2+ Metastatic Breast Cancer

NCT ID: NCT05291910

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-12
• Study Completion Date: 2025-12-31

Brief Summary

This is a multi-center, prospective, interventional, single-arm clinical trial. In the study, patients with her2-positive recurrent or metastatic breast cancer who were initially treated were included. The purpose of this study is to evaluate the efficacy and safety of Inetetamab combined with anti-PD-1 monoclonal antibody and albumin-bound paclitaxel for HER2+ Metastatic Breast Cancer.

Detailed Description

This is a multi-center, prospective, interventional, single-arm clinical trial. In the study, patients with her2-positive recurrent or metastatic breast cancer who were initially treated were included. The purpose of this study is to evaluate the efficacy and safety of Inetetamab combined with anti-PD-1 monoclonal antibody and albumin-bound paclitaxel for HER2+ Metastatic Breast Cancer.To explore a new concept of anti-HER2 monoclonal antibody combined with immunotherapy in the treatment of recurrent or metastatic breast cancer. The primary end point is progression free survival (PFS). The secondary end points are objective response rate (ORR), Clinical Benefit Rate (CBR) and safety assessment.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inetetamab+ Toripalimab+ Albumin-Bound Paclitaxel

Drug: Inetetamab Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30 to 90 minutes IV infusion every three weeks Drug: Toripalimab 240mg intravenously every 3 weeks Drug: Albumin-Bound Paclitaxel 130mg/m2, IV , D1, D8, q3w

Group Type: EXPERIMENTAL

Inetetamab

Intervention Type: DRUG

Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30 to 90 minutes IV infusion every three weeks

Toripalimab

Intervention Type: DRUG

240mg intravenously every 3 weeks

Albumin-Bound Paclitaxel

Intervention Type: DRUG

130mg/m2, IV , D1, D8, q3w

Interventions

Inetetamab

Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30 to 90 minutes IV infusion every three weeks

Intervention Type: DRUG

Toripalimab

240mg intravenously every 3 weeks

Intervention Type: DRUG

Albumin-Bound Paclitaxel

130mg/m2, IV , D1, D8, q3w

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Female patients aged > 18 years.

2. Pathological diagnosis of HER-2 was positive (definition: immunohistochemical results were + + + or ICH++ with fluorescence in situ hybridization results were positive).

3. Participants must have histologically or cytologically confirmed invasive breast cancer with locally recurrent or radiological evidence of metastatic disease.

4. Patients with locally recurrent inoperable or metastatic HER2-positive breast cancer:

1. patients with metastatic breast cancer at the time of initial diagnosis, meaning there was no previous history of breast cancer in the past; or

2. patients with Locally recurrent or metastatic breast cancer, neoadjuvant/adjuvant anti-HER2 therapy has been completed for ≥6 months.

5. HER2-positive recurrent or metastatic BC patients who have received at most one anti-HER2 therapy after diagnosis;.

6. PD-L1-positive (cut-off ≥ 1% stained cells);

7. Patients with assessable target lesion as per RECIST 1.1 and irRECIST criteria.

8. ECOG PS score 0 or 1, estimated survival time ≥3 months, and can be followed-up.

9. Cardiopulmonary function is basically normal.

10. Liver function is basically normal.

11. Have sufficient baseline hematology parameters.

12. Coagulation Indicators: International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 times the upper limit of normal, unless drugs known to change INR and aPTT are used.

13. No history of serious heart, kidney and other important organs and endocrine disease.

14. Female patients of childbearing age have a negative pregnancy test and voluntarily take effective and reliable contraceptive measures.

15. The patients voluntarily signed an informed consent form.

Exclusion Criteria

1. Participated in other clinical trials within 4 weeks;

2. Evidence of symptomatic central nervous system metastasis or pia mater disease.

3. History of receiving CD137 agonists or checkpoint blockade therapy (including anti-CD40, anti-CTLA-4, anti-PD-1, anti-PD-L1 monoclonal antibody therapy).

4. History of receiving paclitaxel for injection (Albumin Bound) in first-line chemotherapy for advanced disease.

5. History of autoimmune disease Including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease (IBD), etc.

6. Immunosuppressive drugs required within 2 weeks before enrollment or during this study. The following conditions are excluded: 1) intranasal, inhalation, topical or local steroid injection (e.g., intra articular injection); 2) physiological doses of systemic corticosteroids (≤ 10 mg/day prednisone or equivalent dose); 3) short term (≤ 7 days) use of steroids to prevent or treat non-autoimmune allergic diseases.

7. History of acute or chronic hepatitis B virus (HBV), or hepatitis C virus (HCV).

8. History of primary or acquired immunodeficiency (including HIV-positive).

9. History of hypersensitivity to the study medication

10. Pregnancy or lactation.

11. History of myocardial infarction within 6 months before enrollment, congestive heart failure (New York Heart Association [NYHA] Classes ≥ II), severe arrhythmia beyond drug control, or a decrease in LVEF to < 50% with previous trastuzumab neoadjuvant or adjuvant treatment.

12. History of other malignant disease within 5 years (except cured of in-situ carcinoma of the cervix, basal cell carcinoma of the skin and squamous cell carcinoma).

13. Participants who were judged by the investigator to be unsuitable for this study .

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

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Binghe Xu

Director of Breast Cancer Section

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Binghe Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Director of Breast Cancer Section

Locations

Cancer Hospital Chinese Academy Of Medical Sciences

Beijing, , China

Countries

China

Central Contacts

Binghe Xu, MD

Role: CONTACT

xubinghe@medail.com.cn

010-67781331

Ying Fan, MD

Role: CONTACT

pearloffan@163.com

010-67781331

Facility Contacts

Binghe Xu, MD

Role: primary

xubinghe@medail.com.cn

010-67781331

Other Identifiers

SPT-2021-002

Identifier Type: -

Identifier Source: org_study_id