^
    1d
    ENCORE: Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer (clinicaltrials.gov)
    P=N/A, N=100, Recruiting, University of California, San Francisco | Not yet recruiting --> Recruiting
    Enrollment open
    1d
    Novel CDK2/4/6 inhibitor culmerciclib (TQB3616) plus fulvestrant in previously treated, HR-positive, HER2-negative advanced breast cancer: a randomized, double-blind, phase 3 trial. (PubMed, Signal Transduct Target Ther)
    In conclusion, this randomized clinical trial met its primary outcome. Culmerciclib plus fulvestrant is well tolerated and leads to a significant gain in PFS of pretreated HR-positive HER2-negative ABC patients.
    Clinical • P3 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    fulvestrant • Setanxin (culmerciclib)
    1d
    Recent treatment and survival trends in older versus younger women with HR-positive HER2-negative metastatic breast cancer in the real-life multicenter French ESME cohort. (PubMed, Eur J Cancer)
    ET+CDK4/6i use rose up to ∼50 % after 2017, reaching ∼70 % in recent years among women with good PS, but remained ∼50 % in older patients with poor PS. Broader adoption is needed, with less chemotherapy use. Survival outcomes have improved but, causality cannot be confirmed due to the observational design.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    2d
    PreEMBER: A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer (clinicaltrials.gov)
    P2, N=600, Not yet recruiting, Eli Lilly and Company
    New P2 trial
    |
    tamoxifen • Inluriyo (imlunestrant) • goserelin acetate
    2d
    Beyond The Age Limit: A Comparative Study (<70 Vs ≥70 Years) in Breast Cancer Characteristics and Surgical Management in Women. (PubMed, Breast Cancer (Dove Med Press))
    These findings demonstrate important differences in disease presentation and surgical management between age groups in Turkey, where breast cancer screening ends at age 69. The absence of screening detection in elderly patients, combined with their advanced disease presentation, highlights the need for further investigation with larger, multicenter cohorts to evaluate optimal screening strategies for women beyond age 69.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative
    2d
    Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy (clinicaltrials.gov)
    P2, N=46, Recruiting, University of Nebraska | Trial completion date: Sep 2031 --> Sep 2032 | Trial primary completion date: Sep 2025 --> Sep 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Ibrance (palbociclib)
    2d
    Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=205, Not yet recruiting, Novartis Pharmaceuticals
    New P1/2 trial
    |
    fulvestrant • letrozole
    2d
    DESTINY-Breast08: A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=138, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2025 --> Jun 2026
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 expression • HER-2 underexpression • PGR positive
    |
    Imfinzi (durvalumab) • paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • fulvestrant • Truqap (capivasertib) • anastrozole
    3d
    HER2 expression in breast cancer: evidence gaps and challenges. (PubMed, NPJ Precis Oncol)
    This evolving landscape challenges the traditional use of HER2 as a diagnostic marker and underscores the need for a deeper understanding of HER2 biology. This review addresses these complexities, focusing on the emerging HER2-Low and Ultralow subtypes, and evaluates the distinct therapeutic responses across the spectrum of HER2 expression in different BC subtypes.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative • HER-2 expression
    4d
    FOURLIGHT-1: A Study to Learn About the Study Medicine Called PF-07220060 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)
    P2, N=333, Active, not recruiting, Pfizer | Trial primary completion date: Sep 2025 --> Mar 2026
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    everolimus • fulvestrant • exemestane • atirmociclib (PF-07220060)
    4d
    The role of circulating tumor cell-associated genes in the progression of estrogen receptor-positive breast cancer. (PubMed, NPJ Breast Cancer)
    Higher CTC signature ITH was associated with increased Oncotype DX risk and higher overall grade. These findings highlight the value of our CTC signature in disease progression and the role of ITH on recurrence risk.
    Journal • Circulating tumor cells
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • EGFR positive • EGFR negative
    |
    Oncotype DX Breast Recurrence Score®Test
    4d
    Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) (clinicaltrials.gov)
    P3, N=701, Active, not recruiting, Celcuity Inc | Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2025 --> Jun 2026
    Enrollment closed • Trial primary completion 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) • Piqray (alpelisib) • fulvestrant • gedatolisib (PF-05212384)