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

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

NCT ID: NCT06125834

Condition: Advanced Breast Cancer
Objective Response Rate
Trastuzumab Emtansine

Conditions: Official terms:
Breast Neoplasms
Disease Progression
Trastuzumab
Ado-Trastuzumab Emtansine
Maytansine

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Trastuzumab Emtansine (T-DM1)
Description: Enrolled patients will receive Trastuzumab Emtansine (T-DM1) treatment (3.6mg/kg, d1/21, IVD) until progressive diseases or intolerable adverse effects occurs.
Arm group label: T-DM1 treatment group

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.

Criteria for eligibility:
Criteria:
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.

Gender: Female

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University

Address:
City: Nanjing
Country: China

Status: Recruiting

Contact:
Last name: Wenbin Zhou, Professor

Phone: 025-68308162
Email: zhouwenbin@njmu.edu.cn

Start date: June 1, 2023

Completion date: May 31, 2026

Lead sponsor:
Agency: The First Affiliated Hospital with Nanjing Medical University
Agency class: Other

Source: The First Affiliated Hospital with Nanjing Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06125834