Status:
RECRUITING
Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Advanced Breast Cancer
Objective Response Rate
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
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 thera...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06125834
Start Date
June 1 2023
End Date
May 31 2026
Last Update
April 16 2024
Active Locations (1)
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1
JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China