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pyrotinib plus capecitabine
Pyrotinib is a tyrosine kinase inhibitor that targets the HER2/neu receptor, while capecitabine is a prodrug of fluorouracil, an antimetabolite that interferes with DNA synthesis.
Pyrotinib is a tyrosine kinase inhibitor that targets the HER2/neu receptor, while capecitabine is a prodrug of fluorouracil, an antimetabolite that interferes with DNA synthesis. Used for Advanced or metastatic breast cancer with HER2 overexpression, Metastatic colorectal cancer.
At a glance
| Generic name | pyrotinib plus capecitabine |
|---|---|
| Also known as | SHR1258, Irene |
| Sponsor | Henan Cancer Hospital |
| Drug class | Tyrosine kinase inhibitor, Antimetabolite |
| Target | HER2/neu, Thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Pyrotinib works by binding to the HER2/neu receptor, preventing its activation and subsequent signaling pathways that promote cell growth and survival. Capecitabine, on the other hand, is converted into fluorouracil, which is then phosphorylated into fluorodeoxyuridine monophosphate (FdUMP) and fluorodeoxyuridine triphosphate (FdUTP). These metabolites inhibit thymidylate synthase, leading to the depletion of thymidine and ultimately, cell death.
Approved indications
- Advanced or metastatic breast cancer with HER2 overexpression
- Metastatic colorectal cancer
Common side effects
- Hand-foot syndrome
- Diarrhea
- Fatigue
- Nausea
- Vomiting
Key clinical trials
- SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study (PHASE2)
- A Trial of SHR-A1811versus Pyrotinib in Combination With Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane (PHASE3)
- Young Patients With Early Breast Cancer
- A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors (PHASE1, PHASE2)
- A Prospective, Open-label, Exploratory Basket Trial to Evaluate the Efficacy and Safety of Sintilimab Combined With Pyrotinib ± Chemotherapy in Patients With Advanced Digestive System Tumors (PHASE2)
- Oral Metronomic Capecitabine Combined With Pyrotinib in ADC-treated HER2-positive Metastatic Breast Cancer (PHASE2)
- Pyrotinib Combined With Trastuzumab for Maintenance Therapy After First-line TH (P) Therapy for HER2+ABC
- Pyrotinib and Subcutaneous Preparation of Trastuzumab Combined With Capecitabine Neoadjuvant Therapy for HER2+ Study of Breast Cancer (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- pyrotinib plus capecitabine CI brief — competitive landscape report
- pyrotinib plus capecitabine updates RSS · CI watch RSS
- Henan Cancer Hospital portfolio CI