^
    17h
    Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) (clinicaltrials.gov)
    P3, N=315, Active, not recruiting, AstraZeneca | Trial completion date: Nov 2027 --> Sep 2028
    Trial completion date • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HR positive • HER-2 negative • ESR1 mutation • HR positive + HER-2 negative • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation • HER-2 negative + HR positive + ESR1 mutation
    |
    Guardant360® CDx
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • letrozole • anastrozole • camizestrant (AZD9833)
    1d
    ADAPTela: Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- eBC (clinicaltrials.gov)
    P3, N=1520, Not yet recruiting, West German Study Group | N=1050 --> 1520
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    ER positive • HR positive • HER-2 negative • HER-2 negative + ER positive
    |
    MammaPrint® • Oncotype DX Breast Recurrence Score®Test
    |
    Kisqali (ribociclib) • Orserdu (elacestrant)
    1d
    A Rare Case of Palbociclib-Induced Pancolitis: Clinical Insights and Literature Review. (PubMed, Cureus)
    While generally well tolerated, their toxicity profiles differ, with palbociclib and ribociclib more commonly associated with hematologic toxicity and abemaciclib with gastrointestinal adverse effects such as diarrhea...We report a 65-year-old woman with metastatic HR+ breast cancer who presented with a two-week history of watery diarrhea (10-12 episodes/day), abdominal cramping, and a 5-pound weight loss while receiving palbociclib, fulvestrant, and denosumab...Although biopsy later demonstrated cytomegalovirus (CMV) positivity, antiviral therapy was deferred given negative CMV PCR and complete clinical resolution. This case highlights an uncommon presentation of palbociclib-induced pancolitis and underscores the importance of careful clinical evaluation and contextual interpretation of histologic findings to avoid unnecessary treatment.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • Prolia (denosumab)
    3d
    Clinical and molecular biomarkers for prediction of endocrine response after short preoperative endocrine therapy in the WSG ADAPT-HR+/HER2- and ADAPTcycle trials (N=7914). (PubMed, Ann Oncol)
    We observed similar ET-response rates in two large phase III trials. Postmenopausal patients (mostly receiving AI) had higher ET-response rates compared to younger patients. However, young patients with GnRH+AI had ET-response rates comparable to postmenopausal patients, suggesting that therapy rather than biology accounts for the difference. Combining ET-response and gene expression assessment could help more luminal eBC patients avoid chemotherapy.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Oncotype DX Breast Recurrence Score®Test
    |
    tamoxifen • Kisqali (ribociclib)
    4d
    Comparative real-world Progression Free Survival of CDK4/6 Inhibitors in HR+/HER2- Breast Cancer Patients with Bone Metastases. (PubMed, Oncologist)
    Ribociclib and abemaciclib may provide superior rwPFS and OS compared to palbociclib in HR+/HER2- mBC patients with bone metastases..
    Journal • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib)
    5d
    PIKALO-2: A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) (clinicaltrials.gov)
    P3, N=920, Recruiting, Eli Lilly and Company | N=274 --> 920
    Enrollment change • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    ER positive • PIK3CA mutation • PGR positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • exemestane • tersolisib (LY4064809)
    6d
    OPERA-02: Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=1000, Recruiting, Olema Pharmaceuticals, Inc.
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Kisqali (ribociclib) • letrozole • palazestrant (OP-1250)
    7d
    Study to Determine the Safety and Efficacy of Ribociclib in Combination With Hormone Therapy and Hypofractionated Radiotherapy in Breast Cancer, With Positive Hormone Receptors and Negative HER2 Status, in Newly Diagnosed, Not Immediately Operable Elderly Patient (CALHYS) (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, Centre Antoine Lacassagne | N=85 --> 0 | Trial completion date: Mar 2033 --> Mar 2026 | Recruiting --> Withdrawn | Trial primary completion date: Oct 2031 --> Mar 2026
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Kisqali (ribociclib)
    8d
    KontRASt-03: Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation (clinicaltrials.gov)
    P1/2, N=74, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Nov 2026 --> Jul 2026 | Trial primary completion date: Nov 2026 --> Jul 2026
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Erbitux (cetuximab) • Mekinist (trametinib) • Kisqali (ribociclib) • opnurasib (JDQ443)
    8d
    FAIM: Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression (clinicaltrials.gov)
    P2, N=57, Active, not recruiting, Royal Marsden NHS Foundation Trust | Recruiting --> Active, not recruiting | N=324 --> 57 | Trial completion date: Sep 2026 --> Jun 2027 | Trial primary completion date: Sep 2026 --> Jun 2027
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 positive • ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • ipatasertib (RG7440) • Pegasys (pegylated interferon α -2a)
    8d
    Ribociclib in Hormone Receptor-positive, HER2-negative Early Breast Cancer With Residual Disease After Neoadjuvant Chemotherapy (clinicaltrials.gov)
    P3, N=446, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative • PGR positive
    |
    MammaPrint®
    |
    Kisqali (ribociclib)
    8d
    Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=86, Recruiting, Nagoya City University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    Kisqali (ribociclib) • anastrozole