Last reviewed · How we verify
Fulvestrant combined with Pyrotinib
Fulvestrant blocks estrogen receptor signaling while pyrotinib inhibits HER2 tyrosine kinase, together targeting hormone receptor-positive and HER2-positive breast cancer through dual pathway inhibition.
Fulvestrant blocks estrogen receptor signaling while pyrotinib inhibits HER2 tyrosine kinase, together targeting hormone receptor-positive and HER2-positive breast cancer through dual pathway inhibition. Used for HER2-positive, hormone receptor-positive metastatic or advanced breast cancer.
At a glance
| Generic name | Fulvestrant combined with Pyrotinib |
|---|---|
| Also known as | FASLODEX combined with Pyrotinib |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Drug class | Selective estrogen receptor degrader (SERD) combined with HER tyrosine kinase inhibitor |
| Target | Estrogen receptor (ER) and HER1/HER2/HER4 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Fulvestrant is a selective estrogen receptor degrader (SERD) that competitively binds to the estrogen receptor and promotes its degradation, eliminating estrogen-driven proliferation in hormone receptor-positive breast cancers. Pyrotinib is a pan-HER tyrosine kinase inhibitor that irreversibly blocks HER1, HER2, and HER4 signaling. This combination addresses tumors with both hormone receptor and HER2 dependency, potentially overcoming resistance mechanisms in advanced breast cancer.
Approved indications
- HER2-positive, hormone receptor-positive metastatic or advanced breast cancer
Common side effects
- Hot flashes
- Nausea
- Fatigue
- Diarrhea
- Rash
- Decreased appetite
Key clinical trials
- Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study (PHASE2)
- Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (PHASE2)
- A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors (PHASE1, PHASE2)
- Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2+ Advanced Breast Cancer(DAP-Her-02) (PHASE2)
- Pyrotinib, Dalpiciclib(SHR6390) and Endocrine Therapy in Subjects With Dual-receptor Positive(ER+/HER2+) Advanced Breast Cancer (PHASE1, PHASE2)
- Exploring Whether Disease-free Intervals Can Guide Endocrine Combined Targeted Therapy for ER+/HER2+ Advanced Breast Cancer (T-sunflower) (PHASE2)
- Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer (PHASE2)
- Palbociclib, Trastuzumab,Pyrotinib and Fulvestrant Treatment in Patients With Brain Metastasis From ER/PR Positive, HER-2 Positive Breast Cancer: A Multi-center, Prospective Study in China (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: