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Fulvestrant injection ;Dalpiciclib Isethionate
This combination uses fulvestrant to block estrogen receptors in breast cancer cells while dalpiciclib inhibits cyclin-dependent kinases 4 and 6 to prevent cell cycle progression.
This combination uses fulvestrant to block estrogen receptors in breast cancer cells while dalpiciclib inhibits cyclin-dependent kinases 4 and 6 to prevent cell cycle progression. Used for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
At a glance
| Generic name | Fulvestrant injection ;Dalpiciclib Isethionate |
|---|---|
| Sponsor | Shandong Suncadia Medicine Co., Ltd. |
| Drug class | Selective estrogen receptor degrader (SERD) + CDK4/6 inhibitor combination |
| Target | Estrogen receptor (ER) and cyclin-dependent kinases 4/6 (CDK4/6) |
| 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, eliminating their function in hormone receptor-positive breast cancer. Dalpiciclib is a CDK4/6 inhibitor that prevents the phosphorylation of retinoblastoma protein, blocking G1/S cell cycle transition. Together, they provide complementary mechanisms to suppress proliferation of hormone-sensitive breast cancer cells.
Approved indications
- Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer
Common side effects
- Neutropenia
- Fatigue
- Nausea
- Hot flashes
- Injection site reactions
Key clinical trials
- A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy. (PHASE3)
- A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer. (PHASE1, 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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