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Placebo,Fulvestrant,Goserelin acetate
Placebo,Fulvestrant,Goserelin acetate is a Selective estrogen receptor degrader (SERD) + GnRH agonist combination Small molecule drug developed by Ahon Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in premenopausal women.
This combination uses fulvestrant to block estrogen receptors in cancer cells and goserelin to suppress ovarian hormone production, while placebo serves as a control arm.
This combination uses fulvestrant to block estrogen receptors in cancer cells and goserelin to suppress ovarian hormone production, while placebo serves as a control arm. Used for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in premenopausal women.
At a glance
| Generic name | Placebo,Fulvestrant,Goserelin acetate |
|---|---|
| Sponsor | Ahon Pharmaceutical Co., Ltd. |
| Drug class | Selective estrogen receptor degrader (SERD) + 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 estrogen receptors, blocking estrogen-driven growth in hormone receptor-positive breast cancer. Goserelin is a GnRH agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased estrogen and progesterone production in premenopausal women. Together, they provide dual hormonal blockade to prevent cancer cell proliferation.
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
- Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) (PHASE3)
- Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant (PHASE3)
- 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)
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:
- Placebo,Fulvestrant,Goserelin acetate CI brief — competitive landscape report
- Placebo,Fulvestrant,Goserelin acetate updates RSS · CI watch RSS
- Ahon Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Placebo,Fulvestrant,Goserelin acetate
What is Placebo,Fulvestrant,Goserelin acetate?
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What is Placebo,Fulvestrant,Goserelin acetate used for?
Who makes Placebo,Fulvestrant,Goserelin acetate?
What drug class is Placebo,Fulvestrant,Goserelin acetate in?
What development phase is Placebo,Fulvestrant,Goserelin acetate in?
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Related
- Drug class: All Selective estrogen receptor degrader (SERD) + GnRH agonist combination drugs
- Target: All drugs targeting Estrogen receptor (ER) + GnRH receptor
- Manufacturer: Ahon Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in premenopausal women
- Compare: Placebo,Fulvestrant,Goserelin acetate vs similar drugs
- Pricing: Placebo,Fulvestrant,Goserelin acetate cost, discount & access