HER2-positive breast cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Only participants who meet all of the following inclusion criteria will be eligible for enrollment in this trial: 1. Age 18 to 80 years; 2.Histologically and/or cytologically confirmed diagnosis of advanced breast cancer; 3.Tumor with confirmed HER2 overexpression or gene amplification in the primary and/or metastatic site (immunohistochemistry [IHC] 3+ or IHC 2+ with fluorescence in situ hybridization [FISH] confirmation); 4.Presence of at least one measurable tumor lesion (according to RECIST 1.1); 5.Complete clinical data relevant to key study endpoints; 6.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 7.Life expectancy greater than 3 months.
Exclusion criteria
Exclusion criteria: 1.Participants who meet any of the following criteria will be ineligible for enrollment in this trial: Incomplete or missing medical records; 2.Symptomatic central nervous system metastasis; 3.Pregnant or breastfeeding women; 4.Presence of other malignancies within the past 5 years (except for adequately treated cervical carcinoma in situ, squamous cell carcinoma of the skin, or controlled basal cell carcinoma of the skin); 5.Any other reason that the investigator deems the participant unsuitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate;Disease Control Rate;Overall Survival;Adverse Events; | — |
Countries
China
Contacts
Tianjin Medical University Cancer Institute and Hospital