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

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Nov 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a treatment called trastuzumab emtansine (T-DM1) for women with advanced HER2-positive breast cancer who have not responded well to previous therapies, specifically targeted treatments like TKIs or HP therapy. The main goals are to see how well T-DM1 works to shrink tumors, understand any side effects that might occur, and explore how the treatment impacts the body's immune response against cancer.

To be eligible for this study, participants need to be 18 years or older, have a confirmed diagnosis of breast cancer that has progressed after previous treatments, and have at least one measurable tumor. They should also be in relatively good overall health, meaning their organs are functioning well and they have no significant heart issues. During the trial, participants will receive T-DM1 every three weeks until their cancer worsens or they experience intolerable side effects. It’s important to know that this study is currently recruiting participants, and those interested should discuss it with their healthcare provider to see if they might qualify.

Gender

FEMALE

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.