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Exploratory Study of Advanced Breast Cancer in HER2 Positive Patients With Failure of Multi-line Therapy Treated by Combination of Inetetamab (Cipterbin) + PD-1 Inhibitor Combined With Utidelone.

NCT04681287 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-09-25

No results posted yet for this study

Summary

This study plans to explore the efficacy and safety of chemotherapy combined with inetetamab and PD-1 inhibitors in HER2 positive advanced breast cancer who failed to receive trastuzumab and TKIs, and explore the dominant population of dual antibody combination to further guide the precise and individualized treatment of advanced HER2 positive breast cancer.

Conditions

  • HER2 Positive Metastatic Breast Cancer

Interventions

DRUG

inetetamab and PD-1 inhibitor combined with chemotherapy.

1. Chemotherapy selected by doctors: albumin bound paclitaxel, vinorelbine, gemcitabine, capecitabine, and aribrin were administered according to clinical routine; 2. The first dose was 8 mg / kg, followed by 6 mg / kg, once every 3 weeks 3. PD-1 inhibitor 200mg D1 every 3 weeks as a cycle Treatment to disease progression or toxicity intolerance, or death from any cause. The efficacy was evaluated every 2 cycles and adverse events were recorded. After 4-6 cycles of treatment, if the patient is intolerable to chemotherapy for any reason, the chemotherapy can be stopped and the combination of inistumab and PD-1 can be continued.

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Min Yan · Henan Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-23
Primary Completion
2021-11-04
Completion
2024-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04681287 on ClinicalTrials.gov