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FCN-437c,Fulvestrant,Goserelin acetate
This combination therapy uses an estrogen receptor degrader (fulvestrant) and a gonadotropin-releasing hormone agonist (goserelin) to suppress estrogen signaling in hormone receptor-positive breast cancer.
This combination therapy uses an estrogen receptor degrader (fulvestrant) and a gonadotropin-releasing hormone agonist (goserelin) to suppress estrogen signaling in hormone receptor-positive breast cancer. Used for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in premenopausal women.
At a glance
| Generic name | FCN-437c,Fulvestrant,Goserelin acetate |
|---|---|
| Sponsor | Ahon Pharmaceutical Co., Ltd. |
| Drug class | Estrogen receptor degrader + GnRH agonist combination |
| Target | Estrogen receptor (ER); GnRH receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Fulvestrant is a selective estrogen receptor degrader (SERD) that binds to and degrades the estrogen receptor, blocking estrogen-driven proliferation. Goserelin is a GnRH agonist that suppresses ovarian estrogen production by downregulating the hypothalamic-pituitary-gonadal axis. Together, they provide dual suppression of estrogen signaling through receptor degradation and hormonal suppression.
Approved indications
- Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in premenopausal women
Common side effects
- Hot flashes
- Injection site reactions
- Vaginal dryness
- Arthralgia
- Fatigue
Key clinical trials
- This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c in Combination With Fluvestrant ± Goseraline Versus Placebo Combined With Fulvestrant ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer. (PHASE3)
- Study of Efficacy, Safety, and Pharmacokinetics of FCN-437c in Combination With Fulvestrant or Letrozole+Goserelin (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 |
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