^
    1d
    Close2HER: A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization (clinicaltrials.gov)
    P=N/A, N=100, Recruiting, Hoffmann-La Roche
    New trial • Real-world evidence
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    1d
    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)
    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
    PF-07104091 as a Single Agent and in Combination Therapy (clinicaltrials.gov)
    P2, N=157, Active, not recruiting, Pfizer | Trial completion date: Mar 2026 --> Dec 2026 | Trial primary completion date: Mar 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Ibrance (palbociclib) • fulvestrant • letrozole • tegtociclib (PF-07104091)
    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
    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
    PERFORM: First-line Palbociclib and Endocrine Therapy for Patients With HR+/HER2- Advanced Breast Cancer in the Real-world Setting. (clinicaltrials.gov)
    P=N/A, N=1407, Active, not recruiting, Pfizer | Trial completion date: Apr 2029 --> Apr 2028 | Trial primary completion date: Apr 2029 --> Apr 2028
    Trial completion date • Trial primary completion date • HEOR • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • fulvestrant • exemestane
    3d
    Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=42, Recruiting, Icahn School of Medicine at Mount Sinai | Trial completion date: Dec 2027 --> Jun 2028 | Trial primary completion date: Dec 2026 --> Jun 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Verzenio (abemaciclib) • bicalutamide