Inetetamab Combined With Pyrotinib Plus Oral Vinorelbine for the Treatment of HER2-positive Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase II Single-arm Clinical Trial of Inetetamab Combined With Pyrotinib Plus Oral Vinorelbine for the Treatment of Patients With HER2-positive Metastatic Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05823623
• Other study ID #: 2022-SR-494
• Status: Recruiting
• Phase: Phase 2
• Start date: February 13, 2022
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Xiang Huang
• Phone: +8613701473675
• Email: lorelai[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this phase 2 single-arm clinical trial, 30 patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment of Inetetamab plus Pyrotinib plus Oral Vinorelbine. The study aimed to access the efficacy and safety of Inetetamab combined with Pyrotinib and Oral Vinorelbine in HER2-positive metastatic breast cancer patients after progression on trastuzumab.

Description:

Trastuzumab is an important agent for the treatment of patients with HER2-positive metastatic breast cancer. However, a considerable number of patients will develop resistance to trastuzumab treatment. Previous studies have shown that multiple mechanisms mediate trastuzumab resistance, such as abnormal extracellular domain of the HER2 receptor, HER3 mutation and activation of bypass signaling pathway. To overcome these resistance mechanisms, the combination of trastuzumab with HER2-targeting tyrosine kinase inhibitor (TKI) is an effective strategy. In this phase 2 single-arm clinical trial, 30 patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment of Inetetamab plus Pyrotinib plus Oral Vinorelbine. The study aimed to access the efficacy and safety of Inetetamab combined with Pyrotinib and Oral Vinorelbine in HER2-positive metastatic breast cancer patients after progression on trastuzumab. The primary end point is Progressive-free Survival (PFS). The secondary end points are Overall Survival (OS), Overall Response Rate (ORR), Clinical Benefit Rate (CBR) and safety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Female, Aged = 18 years.

2. Metastatic breast cancer confirmed by pathology or imaging.

3. Pathological diagnosis of HER2 positive (definition: immunohistochemical (IHC) 3+, or IHC 2+ with in situ hybridization (ISH) testing of amplification.

4. Previously received trastuzumab treatment.

5. At least one Measurable target lesion according to RECIST 1.1.

6. Eastern Cooperative Oncology Group (ECOG) score 0- 2.

7. Sufficient organ function: Neutrophil count (ANC) = 1.5 × 10 ^ 9 / L, Platelet count (PLT) = 100 × 10 ^ 9 / L, hemoglobin (Hb) =90 g/L,total bilirubin (TBIL) = 1.5 × upper limit of normal value (ULN), alanine aminotransferase (ALT / AST) = 2.5 × ULN (liver metastasis patients = 5×ULN), serum creatinine = 1.5 × ULN or creatinine clearance rate (CCR) = 60 ml/min, Left ventricular ejection fraction (LVEF) =50%.

Exclusion Criteria:

1. Allergic to the ingredients of the study drug.

2. Symptomatic brain or meningeal metastasis.

3. Gastrointestinal dysfunction or gastrointestinal diseases (including active ulcers).

4. LVEF <50%; clinical manifestations of patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, and severe valvular disease.

5. Any other medical, social or psychological conditions which are inappropriate to participate in this trial.

6. Pregnant or lactating women, women of childbearing age who refused to take effective contraceptive measures during the study period.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Inetetamab
Patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment.
• Pyrotinib
Patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment.
• Oral Vinorelbine Tartrate
Patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment.

Locations

Country	Name	City	State
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploration of biomarkers	To explore the potential biomarkers for the efficacy of combined therapy. The biomarkers will be tested by next-generation sequence	1 year
Primary	Progression Free Survival,PFS	The time from the beginning of treatment to the progression or death of the patient	2 years
Secondary	overall survival,OS	The time from the beginning of treatment to the death of the patient	4 years
Secondary	Objective Response Rate,ORR	The percentage of participants whose best overall response, according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, is either complete response (CR) or partial response (PR)	2 year
Secondary	Clinical Benefit Rate,CBR	the percentage of participants whose best overall response, is either CR, PR or stable disease (SD) lasting for at least 24 weeks	2 year
Secondary	adverse events	The probability and severity of adverse reactions related to the treatment were assessed by CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v5.0.	2 years