Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT06125834
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06125834
Study Brief:
Protocol Section:
NCT06125834