Inetetamab Combined With Pyrotinib and Vinorelbine as First-line to Third-line Treatment for HER2-positive Metastatic Breast Cancer

NCT05764941 | Unknown FDA Drug

• 1 other identifier: ILLUMINE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a real world study to evaluate the efficacy and safety of inetetamb combined with pyrotinib and vinorelbine as first-line to third-line treatment after trastuzumab progression in HER2-positive metastatic breast cancer.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS)

  Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.

  2 years

• Objective Response Rate (ORR)

  The overall response rate is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set

  2 years

Secondary Outcomes (1)

• The Number of Participants Who Experienced Adverse Events (AE)

  2 years

Study Arms (1)

Observational Group

Patients receive initetamab combined with pyrotinib and vinorelbine after trastuzumab progression.

Drug: Inetetamab; Drug: Pyrotinib; Drug: Vinorelbine

Interventions

Inetetamab DRUG

8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle.

Observational Group

Pyrotinib DRUG

400mg, oral, every day.

Observational Group

Vinorelbine DRUG

25 mg/m2, D1, D8, every 3 weeks for one cycle.

Observational Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HER2-positive metastatic breast cancer patients received inetetamab combined with pyrotinib and vinorelbine after trastuzumab failure

You may qualify if:

• Female and 18-80 years old;
• The patient was diagnosed as HER2-positive breast cancer by histopathology (HER2 positive (IHC +++ or IHC++ but FISH/CISH+ ));
• All patients have previously received ≤ 2 lines chemotherapy for metastatic breast cancer;
• Patients received inetetamab combined with pyrotinib and vinorelbine after trastuzumab failure;
• According to RECIST 1.1, patients with at least one target lesion or simple bone metastasis can be evaluated;
• ECOG score of physical status was less than 2, and the expected survival time was not less than 3 months;
• Complete and traceable medical data.

You may not qualify if:

• Incomplete medical data;
• The investigator believes that the patient is not suitable to enter this study.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinib; Vinorelbine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Central Study Contacts

Yongmei Yin

CONTACT

02568307102; ymyin@njmu.edu.cn

Wei Li

CONTACT

02568307102; real.lw@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: January 1, 2020
• Primary Completion: March 1, 2024
• Study Completion: March 31, 2024
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)