^
    1d
    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
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    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)
    2d
    Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive/HER2-Negative Advanced Breast Cancer With Brain Metastases (clinicaltrials.gov)
    P2, N=46, Not yet recruiting, Nanfang Hospital, Southern Medical University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    AiRuiKang (dalpiciclib)
    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)
    5d
    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)
    6d
    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
    A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment. (clinicaltrials.gov)
    P3, N=400, Recruiting, Pfizer
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    everolimus • fulvestrant • exemestane • prifetrastat (PF-07248144)
    7d
    Economic Evaluation of Inavolisib Combined With Palbociclib-Fulvestrant for PIK3CA-Mutated, HR+/HER2- Advanced Breast Cancer in USA. (PubMed, Technol Cancer Res Treat)
    To achieve cost-effectiveness at WTP thresholds of $100,000, $150,000, and $200,000 per QALY, the per-cycle price of inavolisib would need to be reduced to 59.5%, 72.0%, and 86.5% of its current price, respectively.ConclusionFor patients with PIK3CA-mutated HR+/HER2- ABC, the inavolisib regimen is not cost-effective in the U.S. healthcare setting. Negotiating price reductions and adjusting decision thresholds based on patient characteristics may be viable strategies to meet the extensive treatment demand in the U.S.
    Journal • HEOR
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    EGFR mutation • HR positive • HER-2 negative • PIK3CA mutation • EGFR positive
    |
    Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)
    7d
    Oncogenic role and potential mechanisms of MYO1B in breast cancer. (PubMed, In Vitro Cell Dev Biol Anim)
    Functional assays in BRCA cells were performed to evaluate the effects of MYO1B on cell proliferation, apoptosis, and sensitivity to tamoxifen and palbociclib. Mechanistically, MYO1B activated the Pi3k-AKT signaling pathway. Our study suggests that MYO1B promotes the progression of BRCA and may serve as a new target for overcoming endocrine therapy resistance.
    Journal • BRCA Biomarker
    |
    BRCA (Breast cancer early onset)
    |
    Ibrance (palbociclib) • tamoxifen
    7d
    CSF1R inhibitors mitigate CDK4/6 inhibitor-induced immunosuppression to increase antitumor immunity in HR+/HER2- breast cancer. (PubMed, Oncogene)
    Pexidartinib inhibited macrophage activity, suppressed STAT3 phosphorylation, reduced ARG1 expression, and increased lymphocyte viability, thereby enhancing the antitumor efficacy of palbociclib in HR + /HER2- breast cancer. These findings reveal a previously unrecognized immunosuppressive mechanism induced by CDK4/6 inhibition and support CSF1R blockade as a promising combination strategy.
    Journal • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • IGF1 (Insulin-like growth factor 1) • FGF7 (Fibroblast Growth Factor 7)
    |
    HR positive • HER-2 negative • EGFR positive
    |
    Ibrance (palbociclib) • Turalio (pexidartinib)
    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
    PROTECT-2: Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=49, Recruiting, The First Affiliated Hospital of Xiamen University | Not yet recruiting --> Recruiting | Trial completion date: May 2027 --> Dec 2027 | Initiation date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2026 --> Mar 2027
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
    |
    EGFR mutation
    |
    Cosela (trilaciclib) • Jiataile (sacituzumab tirumotecan)