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

• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05764941
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 51
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Drug: Inetetamab; Drug: Pyrotinib; Drug: Vinorelbine

Detailed Description

HER2-positive breast cancers account for 15%-20% of all breast cancers. Despite trastuzumab has significantly improved the survival of patients with HER2-positivie metastatic breast cancer as the first-line standard treatment, the selection of drugs after trastuzumab treatment failure remains difficulty and challenge. Inetetamab, a new antibody to optimize the ADCC effect, has shown great effectiveness in treating HER2-positive metastatic breast cancer, but therapies subsequent to trastuzumab progression are still controversial. Pyrotinib, another second-line HER2 targeted drug, is a typical representative of TKI drugs, which not only has a strong HER2 antagonistic effect but also can synergize with monoclonal antibodies to amplify the ADCC effect. Here, we investigated the efficacy and safety of inetetamb combined with pyrotinib and vinorelbine as first-line to third-line treatment after trastuzumab progression, so as to provide new ideas for the treatment of patients with HER2-positive metastatic breast cancer.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Real World Study of Inetetamab Combined With Pyrotinib and Vinorelbine as First-line to Third-line Treatment for Trastuzumab Resistant HER2-positive Metastatic Breast Cancer: a Multicenter, Retrospective Study
• Actual Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Observational Group Patients receive initetamab combined with pyrotinib and vinorelbine after trastuzumab progression.	Drug: Inetetamab; 8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle.; Drug: Pyrotinib; 400mg, oral, every day.; Drug: Vinorelbine; 25 mg/m2, D1, D8, every 3 weeks for one cycle.

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [2 years]

   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. Objective Response Rate (ORR) [2 years]

   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

Secondary Outcome Measures

1. The Number of Participants Who Experienced Adverse Events (AE) [2 years]

   Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Female and 18-80 years old;

2. The patient was diagnosed as HER2-positive breast cancer by histopathology (HER2 positive (IHC +++ or IHC++ but FISH/CISH+ ));

3. All patients have previously received ≤ 2 lines chemotherapy for metastatic breast cancer;

4. Patients received inetetamab combined with pyrotinib and vinorelbine after trastuzumab failure;

5. According to RECIST 1.1, patients with at least one target lesion or simple bone metastasis can be evaluated;

6. ECOG score of physical status was less than 2, and the expected survival time was not less than 3 months;

7. Complete and traceable medical data.

Exclusion Criteria:

1. Incomplete medical data;

2. The investigator believes that the patient is not suitable to enter this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jiangsu Provincial People's Hospital	Nanjing	Jiangsu	China

Sponsors and Collaborators

• The First Affiliated Hospital with Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The First Affiliated Hospital with Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT05764941
• Other Study ID Numbers: ILLUMINE
• First Posted: Mar 13, 2023
• Last Update Posted: Mar 20, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Vinorelbine

Study Results

No Results Posted as of Mar 20, 2023