^
    1d
    PROMISE: Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy (clinicaltrials.gov)
    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
    Trial completion date • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Ibrance (palbociclib)
    1d
    Liver Resection after Disease Control with Abemaciclib for Solitary Liver Metastasis from Breast Cancer: A Case Report. (PubMed, Surg Case Rep)
    This case represents a rare report of surgical resection for breast cancer liver metastasis after CDK4/6 inhibitor-based therapy. It suggests that local treatment may be effective even in cases with suspected endocrine-resistant disease and provides practical insight into patient selection and treatment strategies, as the case fulfilled previously reported criteria for local therapy.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • EGFR positive
    |
    Verzenio (abemaciclib) • fulvestrant
    2d
    Real-world data on patients with HR+, HER2- early breast cancer prescribed with abemaciclib adjuvant therapy for 2 years in Japan. (PubMed, Future Oncol)
    This study demonstrates that adjuvant abemaciclib+ET is being used at the labeled dosage in most Japanese patients. Furthermore, 2-year completion rates in patients with 2-year follow-up were comparable to the clinical trial data from monarchE (69%).
    Journal • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • EGFR positive
    |
    Verzenio (abemaciclib)
    2d
    18F-Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography Guided Stereotactic Body Radiation Therapy in Advanced Breast Cancer Patients Treated WithCyclin-Dependent Kinase 4/6 Inhibitors. (PubMed, Adv Radiat Oncol)
    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.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • EGFR positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib)
    2d
    CAAA603B12101: [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=48, Recruiting, Novartis Pharmaceuticals | Active, not recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Kisqali (ribociclib) • fulvestrant • goserelin acetate • AAA603
    2d
    Study of Abemaciclib in Dedifferentiated Liposarcoma (clinicaltrials.gov)
    P2, N=33, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2026 --> Jul 2027 | Trial primary completion date: Jul 2026 --> Jul 2027
    Trial completion date • Trial primary completion date
    |
    Verzenio (abemaciclib)
    3d
    Time-resolved proteomic and phosphoproteomic analysis reveals convergent and divergent biological perturbations induced by FDA-approved CDK4/6 inhibitors in hormone receptor-positive breast cancers. (PubMed, Acta Pharmacol Sin)
    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.
    FDA event • Journal
    |
    AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    HR positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib)
    4d
    Evaluating total tumor load (TTL) to predict metastasis in four or more axillary lymph nodes in HR +/HER2- breast cancer patients: the TULIP4N + study. (PubMed, Clin Transl Oncol)
    TTL measured using OSNA predicts ≥ 4 metastatic LNs in patients with luminal-like BC, with a proposed optimal threshold of 100,000 copies/µL.
    Clinical • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRT19 (Keratin 19)
    |
    HER-2 negative
    |
    Verzenio (abemaciclib)
    5d
    riboADHERE: Adherence and Safety of Ribociclib Plus Aromatase Inhibitors in Patients With Early Stage, HR+ and HER2- Breast Cancer (clinicaltrials.gov)
    P4, N=90, Not yet recruiting, Institute of Oncology Ljubljana
    New P4 trial
    |
    Kisqali (ribociclib)
    5d
    ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer (clinicaltrials.gov)
    P1, N=46, Completed, Ono Pharmaceutical Co., Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • letrozole • BMS-986310
    5d
    Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial (clinicaltrials.gov)
    P3, N=1978, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Initiation date: Jul 2026 --> Feb 2027
    Enrollment open • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • ER negative • HER-2 negative + ER positive
    |
    Oncotype DX Breast Recurrence Score®Test
    |
    Kisqali (ribociclib) • letrozole • anastrozole • exemestane
    5d
    Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor (clinicaltrials.gov)
    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
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    Ibrance (palbociclib) • fulvestrant