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    BIOMARKER:

    HR positive + HER-2 negative

    i
    Other names: ESR1, Era, ESR, NR3A1, ER, ER beta, PGR, Progesterone receptor, Nuclear receptor subfamily 3 group C member 3, NR3C3, ERBB2, CD340, HER-2, HER2, NEU, NGL, V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2
    Entrez ID:
    2064; 2099; 5241
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    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
    |
    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)
    4d
    Background parenchymal enhancement as a predictor of invasive disease-free survival in hormone receptor-positive, HER2-negative breast cancer. (PubMed, Eur J Radiol)
    Therefore, the lack of details regarding the timing of the MRI and possible treatment effects constitutes a limiting factor in terms of the internal validity of the model and the clinical interpretation of the findings. Additionally, although almost all patients (99.8%) in the study were reported to have received endocrine therapy, establishing a relationship between BPE and BPE based on the type or response to treatment could strengthenthe study.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Oncotype DX Breast Recurrence Score®Test
    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)
    5d
    TQB3616-III-03: Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer (clinicaltrials.gov)
    P3, N=1946, Active, not recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    tamoxifen • letrozole • anastrozole • Saitanxin (culmerciclib)
    5d
    A Feasibility Trial of a Web Based App Intervention in Hormone Positive Breast Cancer Patients to Improve Adherence to Endocrine Therapy (clinicaltrials.gov)
    P=N/A, N=21, Terminated, Emory University | N=30 --> 21 | Trial completion date: Jun 2026 --> Dec 2025 | Recruiting --> Terminated; Insufficient Staff
    Enrollment change • Trial completion date • Trial termination
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    6d
    Oral selective estrogen receptor degraders in hormone receptor-positive, HER2-negative advanced breast cancer: a systematic review and meta-analysis. (PubMed, Breast Cancer Res Treat)
    Pooled randomized evidence supports a clinically meaningful benefit of oral SERDs over standard ET after endocrine progression in HR + /HER2-ABC, with the strongest and most consistent efficacy observed in ESR1-mutated disease.
    Clinical • Retrospective data • Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HR positive • HER-2 negative • ESR1 mutation • HR positive + HER-2 negative • HER-2 negative + HR positive + ESR1 mutation • HER-2 negative + HR positive + ESR1 wild-type
    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)
    6d
    Molecular Surveillance In Early Breast Cancer Using The Tumor-Informed ctDNA Assay Myriad Genetics Precise MRD Test; A Prospective Observational Multicenter Study (The MRD Molecular Surveillance Study) (clinicaltrials.gov)
    P=N/A, N=0, Withdrawn, M.D. Anderson Cancer Center | N=300 --> 0 | Trial completion date: Dec 2033 --> Apr 2026 | Initiation date: Aug 2026 --> Apr 2026 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2031 --> Apr 2026
    Enrollment change • Trial completion date • Trial initiation date • Trial withdrawal • Trial primary completion date • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA (Breast cancer early onset)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative • BRCA mutation • HER-2 negative + HR positive + BRCA mutation
    6d
    Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=79, Recruiting, Henan Cancer Hospital | Not yet recruiting --> Recruiting | Trial completion date: Dec 2024 --> May 2027 | Trial primary completion date: Dec 2024 --> Dec 2026
    Enrollment open • 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
    |
    Avastin (bevacizumab) • utidelone IV (UTD1)
    7d
    HDAC inhibitor tucidinostat and metronomic capecitabine plus endocrine therapy for patients with HR-positive HER2-negative advanced breast cancer after CDK4/6 inhibitors treatment: clinical findings and exploratory circulating tumor cell and ctDNA biomarker analyses of a multicenter, phase 2 study (SYSUCC-020 trial). (PubMed, Signal Transduct Target Ther)
    This trial adopted a Simon two-stage design: eligible patients received tucidinostat plus metronomic capecitabine together with either an aromatase inhibitor (Cohort 1) or fulvestrant (Cohort 2), selected according to prior ET. In addition, exploratory analyses of biomarkers indicated that the baseline TP53 mutation status (Wild type vs. mutated, 7.64 months vs. 3.55 months) and circulating tumor cell (CTC) status (CTC-negative vs. CTC-positive, 7.59 months vs. 3.78 months) were associated with the median PFS. Our study demonstrated that tucidinostat combined with mCAP and ET is efficacious and well-tolerated in patients with HR-positive HER2-negative ABC previously treated with CDK4/6i.
    P2 data • Journal • Circulating tumor cells • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53)
    |
    HER-2 positive • TP53 mutation • HR positive • HER-2 negative • EGFR positive • HR positive + HER-2 negative
    |
    capecitabine • fulvestrant • Epidaza (chidamide)
    9d
    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)
    9d
    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