Breast Cancer
Conditions
Interventions
Group of Breast Cancer:Non-intervention
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: ? Have signed the informed consent. ? Diagnosed with HER2-positive, unresectable locally advanced or metastatic breast cancer before the start of T-DM1 treatment. ? Had prior treatment for breast cancer which must contain a taxane and trastuzumab. Patients should have either: - received prior therapy for locally advanced or metastatic disease, or - developed disease recurrence during or within 6 months of completing adjuvant therapy. ? Get the treatment of T-DM1 for the first time after diagnosis of breast cancer. ? Females. ? Age = 18 years old at the initiation of T-DM1.
Exclusion criteria
Exclusion criteria: ? Patients not receiving treatment for HER2-positive breast cancer with T DM1 according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling. ? Has been previously treated with T-DM1 before current clinical visit. ? Platelet count = 50*109/L or = 50,000/mm3 when initiate the treatment of T DM1. ? Currently participating in any clinical trials. ? Previously participated in any clinical trials investigating anti-HER2 drug within 1 year of the initiation of T-DM1 and received the treatment of investigational drug. ? At the investigator’s discretion, any reason that makes the patient unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| laboratory tests;vital signs;ECG;echocardiogram; | — |
Countries
China
Contacts
Public ContactXu Binghe
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed