Treatment of advanced HER2-positive breast cancer with T-DM1 after previous therapies
Trastuzumab Emtansine (T-DM1) Treatment in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy: a Multicenter, Single-arm, Phase II Study
This study is testing if a drug called T-DM1 can help people with advanced HER2-positive breast cancer who haven't responded well to other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Drugs / interventions | trastuzumab |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06125834 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of trastuzumab emtansine (T-DM1) in patients with advanced HER2-positive breast cancer who have experienced disease progression after treatment with tyrosine kinase inhibitors (TKIs) or other HER2-targeted therapies. Participants will receive T-DM1 at a dosage of 3.6 mg/kg on day 1 of a 21-day cycle until disease progression or intolerable side effects occur. The study aims to assess the objective response rate, adverse events, and changes in anti-tumor immunity during treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced HER2-positive breast cancer who have progressed after prior anti-HER2 therapies.
Not a fit: Patients with early-stage breast cancer or those who have not received prior anti-HER2 therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced HER2-positive breast cancer who have limited treatment alternatives.
How similar studies have performed: Other studies have shown promising results with T-DM1 in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Wenbin Zhou, Ph.D
- Email: zhouwenbin@njmu.edu.cn
- Phone: +86 13814162016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.