Actively Recruiting
Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-04-16
36
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older; negative pregnancy test for premenopausal and perimenopausal patients, with reliable contraception during treatment
- Diagnosed with invasive breast cancer per AJCC 8th edition and disease progression after anti-HER2 therapy (TKIs) for stage IV or within one year of adjuvant HP therapy after surgery
- At least one measurable lesion according to RECIST 1.1
- ECOG performance status of 0 or 1
- Good organ function with hemoglobin ≥90g/L, white blood cells ≥3.5×10^9/L, platelets ≥100×10^9/L, neutrophils ≥1.5×10^9/L, liver enzymes ≤3×ULN, total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN
- No myocardial ischemia on ECG
- NYHA grade I; echocardiography LVEF ≥55%; normal cardiac markers (cTnI and BNP)
- Completion of all baseline laboratory and radiological tests before treatment
- Complete clinical data available
You will not qualify if you...
- Male breast cancer or inflammatory breast cancer
- Other malignant tumors within past 5 years except treated and controlled basal cell carcinoma of skin or carcinoma in situ of cervix
- Receiving other anti-tumor treatments or participating in other clinical trials
- Serious diseases affecting compliance or posing risk
- Major surgery within 4 weeks before treatment or planned during study
- Previous or current use of antibody-drug conjugate drugs
- History of allergic reactions or contraindications to study drugs
- Chronic diarrhea, intestinal obstruction, or other conditions affecting drug absorption
- Uncontrolled cardiac conditions including heart failure above NYHA II, unstable angina, myocardial infarction within one year, significant arrhythmias requiring treatment
- Dementia, intellectual disability, or mental illness interfering with informed consent understanding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
W
Wenbin Zhou, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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