Breast cancer
Conditions
Interventions
Treatment group:Paclitaxel oral solution combined with trastuzumab for subcutaneous Injection and pyrotinib
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18-70 years 2. HER2-positive breast cancer defined as immunohistochemistry (IHC) 3+ or IHC 2+ with FISH positivity 3. Histologically or cytologically confirmed and documented invasive breast cancer with metastatic or locally recurrent disease not amenable to curative resection 4. Previously untreated with first-line anti-HER2 therapy, or having achieved a response to anti-HER2 agents in the (neo)adjuvant setting with a treatment-free interval of more than 12 months 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 with expected survival of at least 6 months 6. At least one measurable lesion according to RECIST version 1.1 7. LVEF of at least 50% 8. Adequate organ function, evidenced by the following laboratory results: 1) absolute neutrophil count (ANC) >= 1.5×10^9/L, platelet count (PLT) >= 100×10^9/L, hemoglobin (Hb) >= 90 g/L 2) total bilirubin (TBIL) <= 1.5×upper limit of normal (ULN), blood urea nitrogen (BUN) <= 1.5×ULN, creatinine (Cr) <= 1.5×ULN; if no liver metastasis evidence, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5×ULN; if liver metastasis present, ALT and AST <= 5×ULN 9. Premenopausal women with negative pregnancy test and willingness to use effective contraception 10. Signed Informed Consent Form
Exclusion criteria
Exclusion criteria: 1. History of other malignancy within the last 5 years prior to first dose of study drug dosing, except for basal/squamous cell skin cancer, cervical or breast carcinoma in situ after curative surgery 2. History of receiving any investigational treatment within 4 weeks prior to first dose of study drug administration (dosing) 3. Received any systemic anti-tumor treatment during the recurrence/metastasis stage (excluding endocrine therapy previously administered for the recurrence/metastasis stage) 4. Receipt of anti-HER2 therapy other than trastuzumab or pertuzumab during the (neo)adjuvant stage 5. Patients who experienced disease progression during (neo)adjuvant trastuzumab therapy, or patients who developed recurrence/metastasis within 12 months after completing (neo)adjuvant systemic therapy 6. Known hypersensitivity to any of the study medications and excipients 7. Patients with clinically significant arrhythmia, myocardial ischemia, severe atrioventricular block, heart failure, or severe valvular heart disease 8. Evidence of symptomatic central nervous system metastasis or leptomeningeal disease 9. Current peripheral neuropathy of Grade 2 or greater(CTCAE v5.0) 10. Patients deemed unsuitable for oral administration of the study drug by the investigator, due to: (1) clinically significant or uncontrolled congenital or acquired gastrointestinal diseases; (2) confirmed diseases that may affect the administration, gastrointestinal delivery, or absorption of the study drug, including intestinal obstruction and inflammatory bowel disease (Crohn’s disease, ulcerative colitis, unclassified inflammatory bowel disease, etc.) 11. Pregnant or lactating women 12.Assessed by the investigator as unable or unwilling to comply with the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival;Clinical Benefit Rate;Quality of Life;Adverse Event; | — |
Countries
China
Contacts
Public ContactHuiping Li
Beijing Cancer Hospital
Outcome results
None listed