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Fulvestrant Prefilled Syringe
Fulvestrant is a selective estrogen receptor degrader (SERD) that binds to and degrades estrogen receptors in hormone receptor-positive breast cancer cells.
Fulvestrant is a selective estrogen receptor degrader (SERD) that binds to and degrades estrogen receptors in hormone receptor-positive breast cancer cells. Used for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer, Hormone receptor-positive breast cancer in postmenopausal women (first-line or subsequent lines of endocrine therapy).
At a glance
| Generic name | Fulvestrant Prefilled Syringe |
|---|---|
| Sponsor | UNICANCER |
| Drug class | Selective estrogen receptor degrader (SERD) |
| Target | Estrogen receptor alpha (ERα) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Fulvestrant competitively binds to estrogen receptors with high affinity and causes their degradation through proteasomal pathways, eliminating both ligand-dependent and ligand-independent signaling. This mechanism differs from aromatase inhibitors by directly destroying the receptor rather than blocking estrogen production, making it effective in hormone receptor-positive breast cancers including those resistant to other endocrine therapies.
Approved indications
- Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer
- Hormone receptor-positive breast cancer in postmenopausal women (first-line or subsequent lines of endocrine therapy)
Common side effects
- Hot flashes
- Injection site pain/reaction
- Asthenia/fatigue
- Nausea
- Vaginal bleeding/discharge
- Headache
- Back pain
Key clinical trials
- Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. (PHASE3)
- Crizotinib in Lobular Breast, Diffuse Gastric and Triple Negative Lobular Breast Cancer or CDH1-mutated Solid Tumours (PHASE2)
- Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer (PHASE3)
- Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant (PHASE2)
- Study of PF-07224826, as a Single Agent or in Combination With Endocrine Therapy in Participants With Breast Cancer and Other Advanced Solid Tumors. (PHASE1)
- Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer (PHASE2)
- Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.
- Palbociclib in Combination With Fulvestrant Versus Fulvestrant in Advanced Breast Cancer: A Real-world Study in China
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:
- Fulvestrant Prefilled Syringe CI brief — competitive landscape report
- Fulvestrant Prefilled Syringe updates RSS · CI watch RSS
- UNICANCER portfolio CI