Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy

Phase 2

Recruiting

• Conditions: Trastuzumab Emtansine; Advanced Breast Cancer; Objective Response Rate
• Interventions: Drug: Trastuzumab Emtansine (T-DM1)

• Registration Number: NCT06125834
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

The goal of this clinical trial is to learn about the efficacy and safety of trastuzumab emtansine (T-DM1) in the treatment of patients with advanced HER2-positive breast cancer after TKIs or HP therapy. The main questions it aims to answer are:

* The objective response rate of patients receiving T-DM1 therapy with advanced HER2-positive breast cancer after TKIs or HP therapy.

* The adverse events and prognosis of patients with advanced HER2-positive breast cancer who receive the T-DM1 therapy.

* Changes of anti-tumor immunity during T-DM1 therapy in patients with advanced HER2-positive breast cancer.

Participants will receive T-DM1 treatment (3.6mg/kg, d1/21, IVD) until progressive diseases or intolerable adverse effects occurs.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-10-29
• Study First Submitted QC: 2023-11-05
• Study First Posted: 2023-11-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Primary Completion: 2025-04-30
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• Age ≥ 18 years; pregnancy test (-) for premenopausal and perimenopausal patients, promising to use reliable contraception during treatment.
• Patients who were be diagnosed with invasive breast cancer according to the eighth edition of American Joint Committee on Cancer (AJCC) staging system, and develop disease progression after anti-HER2 therapy (TKIs) for stage IV disease at initial diagnosis or within one year of adjuvant anti-HER2 therapy (HP) after surgery for early breast cancer.
• At least one measurable lesion according to RECIST 1.1.
• ECOG score of 0 or 1.
• The organ function is still good and meets the following indicators: hemoglobin ≥ 90g/L, white blood cell ≥ 3.5×10^9/L, platelet ≥ 100×10^9/L, neutrophil ≥ 1.5×10^9/L, aspartate aminotransferase or alanine aminotransferase ≤ 3×ULN, total bilirubin ≤ 1.5×ULN, serum creatinine value ≤ 1.5×ULN.
• Without myocardial ischemia in ECG.
• NYHA grade I; Echocardiography LVEF ≥55%; Cardiac markers: cardiac troponin (cTnI) and brain natriuretic peptide (BNP) within normal range.
• Complete all necessary baseline laboratory and radiological tests prior to treatment.
• Complete clinical data.

Exclusion Criteria

• male breast cancer or inflammatory breast cancer.
• Patients who have other malignant tumors or have contracted malignant tumors other than breast cancer in the past 5 years, except for basal cell carcinoma of the skin or flat cell carcinoma and carcinoma in situ of the cervix that have been adequately treated and controlled.
• Accompanying other anti-tumor treatments or participating in other clinical trials.
• Serious diseases that will affect the patient's compliance or put the patient at risk.
• Major surgical procedures performed within 4 weeks prior to the commencement of study treatment or anticipated major surgical procedures during the course of the study.
• Patients who have used ADC drugs at present or before this study.
• History of allergic reactions or contraindications to use of any drug ingredient in this study.
• Patients with chronic diarrhea and intestinal obstruction, as well as other diseases that affect drug administration and absorption.
• Patients who have clinical cardiac symptoms or diseases that are not well controlled, such as: heart failure above NYHA 2; unstable angina; myocardial infarction occurred within one year; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
• Dementia, intellectual abnormality, or any mental illness that interferes with the understanding of informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
T-DM1 treatment group	Trastuzumab Emtansine (T-DM1)	Trastuzumab Emtansine (T-DM1), 3.6mg/kg, d1/21, IVD, until progressive diseases or intolerable adverse effects occurs

Primary Outcome Measures

Name	Time	Method
Objective response rate	up to 12 months

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	up to 36 months
Tumor related parameters	up to 12 weeks	Tumor heterogeneity before and after treatment its correlation with objective response rate, progression-free survival, overall survival, etc.
Overall survival	up to 36 months
Adverse events	every 6 weeks
Antitumor immunity related parameters	up to 12 weeks	The changes of composition and function of immune cells in the tumor and peripheral blood before and after treatment

Trial Locations

Locations (1)

JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China