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Fulvestrant in combination with abemaciclib
Fulvestrant blocks estrogen receptors while abemaciclib inhibits CDK4/6, together suppressing hormone-driven breast cancer cell growth through dual pathway inhibition.
Fulvestrant blocks estrogen receptors while abemaciclib inhibits CDK4/6, together suppressing hormone-driven breast cancer cell growth through dual pathway inhibition. Used for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
At a glance
| Generic name | Fulvestrant in combination with abemaciclib |
|---|---|
| Sponsor | Sermonix Pharmaceuticals Inc. |
| Drug class | Selective estrogen receptor degrader (SERD) + CDK4/6 inhibitor combination |
| Target | Estrogen receptor (ER) and CDK4/CDK6 |
| 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 estrogen-dependent signaling in breast cancer cells. Abemaciclib is a CDK4/6 inhibitor that blocks cell cycle progression by preventing the transition from G1 to S phase. Together, this combination targets both the estrogen receptor pathway and cell cycle checkpoints, providing complementary mechanisms to overcome resistance and improve efficacy in hormone receptor-positive breast cancer.
Approved indications
- Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer
Common side effects
- Neutropenia
- Diarrhea
- Fatigue
- Nausea
- Abdominal pain
- Infection
Key clinical trials
- A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (PHASE1)
- A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) (PHASE3)
- Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer (PHASE1, PHASE2)
- Evaluating Cancer Response to Treatment With Abemaciclib and Fulvestrant in Women With Recurrent Endometrial Cancer (PHASE2)
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (PHASE1, PHASE2)
- A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) (PHASE3)
- A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread (PHASE1)
- Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (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 |