^
    1d
    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)
    1d
    Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=63, Not yet recruiting, Regor Pharmaceuticals Inc.
    New P1 trial • First-in-human
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    2d
    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
    2d
    Radiomics Nomogram Based on Multiparametric MRI for Predicting the Hormone Receptor Status of HER2-Low Expression Breast Cancer. (PubMed, J Comput Assist Tomogr)
    An mpMRI-based nomogram incorporating radscore and clinical-radiological characteristics showed good predictive efficacy for assessing the HR status of HER2-low expression breast cancer.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 expression • HER-2 underexpression
    2d
    Targeted Therapies for Each Subtype of Breast Cancer. (PubMed, MedComm (2020))
    This review comprehensively summarizes recent advances in targeted therapies for major BC subtypes: endocrine therapy combined with cyclin-dependent kinase 4/6 (CDK4/6) or phosphatidylinositol 3-kinase (PI3K)/protein kinase B (AKT)/mammalian target of rapamycin (mTOR) inhibitors for HR-positive BC; novel antibody‒drug conjugates (ADCs) such as trastuzumab deruxtecan (T-DXd) and tyrosine kinase inhibitors (TKIs) for HER2-positive BC; and trophoblast cell-surface antigen 2 (Trop-2) ADCs, immunotherapies, and poly-ADP-ribose polymerase (PARP) inhibitors for TNBC. It also discusses cross-subtype therapeutic platforms (ADCs, PI3K/AKT/mTOR pathway) and emerging modalities (chimeric antigen receptor [CAR] T-cell therapy, proteolysis-targeting chimeras [PROTACs]). By analyzing successes, challenges, and translational potential, this review provides a clear framework for clinicians and researchers, advancing personalized treatment optimization and addressing unmet clinical needs in BC precision oncology.
    Review • Journal • PARP Biomarker • IO biomarker
    |
    ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 positive • HR positive • EGFR positive
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    2d
    Impact of Time of Administration, Fasting, and a Low-Carbohydrate Diet on Alpelisib-Associated Hyperglycemia and Efficacy: A Pilot Randomized Controlled Phase IIb Trial. (PubMed, Cancers (Basel))
    Background: Alpelisib plus fulvestrant improves outcomes in PIK3CA-mutated, hormone receptor-positive, HER2-negative metastatic breast cancer. Evening alpelisib preceded by fasting and low-carbohydrate guidance may improve metabolic tolerability without compromising efficacy or QoL. These findings support evaluation in a larger trial incorporating prospective metabolic adherence and pharmacokinetic assessments.
    P2b data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HR positive • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative
    |
    Piqray (alpelisib) • fulvestrant
    2d
    The Evolution of Targeted Therapies in Early Hormone Receptor-Positive, HER2-Negative Breast Cancer. (PubMed, Cancers (Basel))
    This manuscript aims to provide a comprehensive overview of the evidence behind endocrine therapy and recommended duration of treatment, genomic assays to guide chemotherapy delivery, data guiding use of bisphosphonate therapy to reduce bone recurrence, and indications for incorporating CDK 4/6 inhibitors. In addition, novel endocrine agents and targeted therapies under investigation are highlighted.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    2d
    Extracellular ATP promotes endocrine resistance in ER+ breast cancer through upregulation of PYGL. (PubMed, Cell Death Dis)
    Moreover, elevated PYGL expression was strongly associated with reduced endocrine therapy sensitivity in breast cancer organoids and clinical tumor specimens. Collectively, these findings identify extracellular ATP-driven PYGL activation as a critical mechanism underlying endocrine resistance and suggest that targeting this pathway may represent a promising strategy to improve endocrine therapy efficacy in breast cancer patients.
    Journal
    |
    ER (Estrogen receptor)
    |
    ER positive • HR positive
    2d
    GCT1047-01: GEN1047 for Solid Tumors - First in Human (FIH) Trial (clinicaltrials.gov)
    P1/2, N=179, Terminated, Genmab | Active, not recruiting --> Terminated; The Sponsor has made a strategic decision to stop the development of GEN1047.
    Trial termination • First-in-human
    |
    GEN1047
    2d
    A Study on the Use of Fluzoparib Combined With Chemotherapy for Neoadjuvant Treatment of HRD-positive, HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P2, N=28, Completed, Xijing Hospital | Recruiting --> Completed | Trial completion date: Dec 2026 --> Mar 2026 | Trial primary completion date: Nov 2026 --> Feb 2026
    Trial completion • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    BRCA2 mutation • ER positive • BRCA1 mutation • HER-2 negative • HRD • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    docetaxel • cyclophosphamide • AiRuiYi (fluzoparib)
    2d
    EVOLVE-BDT: Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (clinicaltrials.gov)
    P2, N=700, Recruiting, UNC Lineberger Comprehensive Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    everolimus • capecitabine • Verzenio (abemaciclib)
    2d
    A Study of HLD-0117 in Patients With Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=33, Recruiting, Halda Therapeutics OpCo, Inc.
    New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive