Advanced Breast Cancer Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | May 31, 2026 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University |
China,
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Swain SM, Miles D, Kim SB, Im YH, Im SA, Semiglazov V, Ciruelos E, Schneeweiss A, Loi S, Monturus E, Clark E, Knott A, Restuccia E, Benyunes MC, Cortes J; CLEOPATRA study group. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Apr;21(4):519-530. doi: 10.1016/S1470-2045(19)30863-0. Epub 2020 Mar 12. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate | up to 12 months | ||
Secondary | Progression-free survival | up to 36 months | ||
Secondary | Overall survival | up to 36 months | ||
Secondary | Adverse events | every 6 weeks | ||
Secondary | Antitumor immunity related parameters | The changes of composition and function of immune cells in the tumor and peripheral blood before and after treatment | up to 12 weeks | |
Secondary | Tumor related parameters | Tumor heterogeneity before and after treatment its correlation with objective response rate, progression-free survival, overall survival, etc. | up to 12 weeks |
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