breast cancer
Conditions
Interventions
Group of breast cancer (pyrotinib and other drugs selected by the doctors):None
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Early breast cancer patients diagnosed as HER2 positive by pathology or histocytology; 3. Plan to receive pyrotinib for neoadjuvant or adjuvant treatment; 4. Have a traceable medical history during treatment; 5. Meet any of the following high-risk conditions: (1) Patients who plan to use pyrotinib for neoadjuvant treatment after 4 cycles of neoadjuvant treatment without pyrotinib and whose tumors have shrunk by <= 50%; (2) Patients who have not obtained pCR after completing a previous neoadjuvant treatment without pyrotinib; (3) Patients with positive axillary lymph nodes in stage II to stage IIIc, according to the breast cancer staging criteria of the American Joint Commission on Cancer (8th edition), (Isolated tumor cells and micrometastasis are respectively considered as pN0 and pN1). Patients who have completed neoadjuvant treatment and only have residual invasive cancer in the breast but have negative lymph nodes or unknown lymph node status are eligible.
Exclusion criteria
Exclusion criteria: 1. Have received neoadjuvant treatment and obtained pCR; 2. Unsigned informed consent form; 3. Pregnant or lactating women; 4. Other situations judged by the researcher not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Remission, ORR;Invasive Disease-free Survival, iDFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;Objective Response Rate, ORR;Progression-Free-Survival, PFS;Time-To-Progression;Clinical Benefit Rate, CBR;Duration of Response, DoR;Safety;Adverse events and Serious adverse events; | — |
Countries
China
Contacts
Public ContactQiang Liu
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed