Ibrance (palbociclib)

P=N/A, N=68, Active, not recruiting, Mayo Clinic | Trial completion date: Mar 2026 --> Mar 2028 | Trial primary completion date: Mar 2026 --> Mar 2028

The majority of patients (72%) were treated in the first-line setting; 11 received ribociclib, 15 received palbociclib, and 3 received abemaciclib. Whether this translates into deferring disease progression requires randomized studies with larger treatment groups. To our knowledge, this study represents the first analysis evaluating 18F-FDG-PET/CT-guided SBRT in combination with CDK4/6 inhibitor-based therapy in patients with metastatic breast cancer.

Palbociclib, ribociclib, and abemaciclib, which are FDA-approved CDK4/6 inhibitors, constitute the standard first-line treatment for advanced hormone receptor-positive (HR+) breast cancers. Collectively, this study deepens the understanding of shared and drug-specific molecular characteristics and mechanisms of CDK4/6 inhibitors at multi-omic levels. Moreover, it provides an experimental basis and potential directions for customizing combination therapies based on pathway vulnerabilities, as well as exploration of novel therapeutic modes and drugs.

P1, N=46, Completed, Ono Pharmaceutical Co., Ltd. | Active, not recruiting --> Completed

P2, N=60, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Jun 2026 --> Dec 2026 | Trial primary completion date: Jun 2026 --> Dec 2026

Guided by precision oncology targeting both immunogenic profile and cell-cycle dysregulation, the patient was treated with dual immunotherapy (pembrolizumab plus ipilimumab) combined with the CDK4/6 inhibitor palbociclib. To our knowledge, this is the first report demonstrating the efficacy of dual checkpoint blockade plus CDK4/6 inhibition in SMARCA4-UT. This case highlights potential of biomarker-driven therapies to overcome resistance in rare thoracic neoplasms.

Palbociclib significantly enhanced this effect, while INK4C-IN-2 significantly reversed this blocking effect. In summary, we found a novel anti-tumor indication of antipsychotic drug perphenazine, which can inhibit the growth of tumor in vitro and in mouse-derived tumor model. These results suggested that perphenazine is also a promising anti-gastric cancer drug in clinical applications.

P=N/A, N=4184, Completed, Pfizer | Not yet recruiting --> Completed | N=1300 --> 4184

This article mainly reviews the mechanisms of action, clinical efficacy, and current application status of CDK4/6 inhibitors, including Palbociclib, Ribociclib, Abemaciclib, and the emerging Dalpiciclib. Strategies such as combining phosphoinositide 3-kinase (PI3K) inhibitors, immunotherapy, or new estrogen receptor (ER)-degrading agents are being actively explored for drug-resistant patients. The personalized precision therapy may become the core direction for optimizing the application of CDK4/6 inhibitors in the future, which will improve patients' quality of life.

A 59-year-old woman with stage IIIA HR+/HER2- breast cancer underwent modified radical mastectomy in 2016, followed by adjuvant AC-P (doxorubicin hydrochloride 70 mg, cyclophosphamide 800 mg, and paclitaxel liposomes 180 mg) chemotherapy, radiotherapy, and letrozole maintenance...Since palbociclib was not yet covered by insurance, she received an initial chidamide + exemestane therapy, which proved ineffective. Using second-line palbociclib combined with fulvestrant and zoledronic acid therapy, disease stabilization was achieved for up to 12 months...As of September 2023, the patient has remained progression-free for >20 months and experienced only manageable grade 2 diarrhea. This case suggests that sequential CDK4/6 inhibition could help achieve >20 months of progression-free disease control in a patient with bone-only HR+/HER2- MBC after clinical progression during prior palbociclib-based therapy and underscored the need for biomarker-guided strategies in this distinct population.

Although immune checkpoint inhibitors such as nivolumab have shown clinical benefit, particularly in patients with high PD-L1 expression, this subgroup represents only a small fraction of eSCC cases. Using a translationally relevant 3D vascularized microfluidic system, we provide evidence that early CDK4/6 inhibition not only stall cancer cell growth but also promotes immune cells recruitment. In conclusion, our study identifies palbociclib as a viable first-line therapeutic candidate in selected eSCC patients and uncover its immunomodulatory potential.