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dalpiciclib + endocrine therapy
Dalpiciclib is a CDK4/6 inhibitor that works by blocking the activity of CDK4/6 enzymes, which are involved in cell cycle progression.
Dalpiciclib is a CDK4/6 inhibitor that works by blocking the activity of CDK4/6 enzymes, which are involved in cell cycle progression. Used for Metastatic breast cancer, hormone receptor-positive and HER2-negative.
At a glance
| Generic name | dalpiciclib + endocrine therapy |
|---|---|
| Sponsor | Fujian Cancer Hospital |
| Drug class | CDK4/6 inhibitor |
| Target | CDK4/6 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting CDK4/6, dalpiciclib prevents the phosphorylation and activation of the retinoblastoma protein, leading to cell cycle arrest and apoptosis in cancer cells. This mechanism is particularly effective in combination with endocrine therapy, which targets hormone receptors in breast cancer cells.
Approved indications
- Metastatic breast cancer, hormone receptor-positive and HER2-negative
Common side effects
- Fatigue
- Nausea
- Diarrhea
- Vomiting
- Abdominal pain
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)
- Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer (PHASE2)
- Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine vs Dalpiciclib Combined With Endocrine Therapy for First-line Treatment (PHASE3)
- CDK4/6 Inhibitors Intensification for Chemotherapy Omission in Small Size High-risk ER-positive Breast Cancer（Cinnamon） (PHASE3)
- Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients (PHASE2, PHASE3)
- ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer (PHASE2)
- Efficacy and Safety of Trastuzumab Rezetecan Followed by CDK4/6 Inhibitors and Endocrine Therapy in HR+/HER2-Low/Ultra-Low Advanced Breast Cancer (PHASE2)
- Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer （EBC） (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- dalpiciclib + endocrine therapy CI brief — competitive landscape report
- dalpiciclib + endocrine therapy updates RSS · CI watch RSS
- Fujian Cancer Hospital portfolio CI