^
    1d
    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
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 negative
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    Ibrance (palbociclib)
    1d
    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
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    fulvestrant • letrozole
    1d
    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)
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    HER-2 expression • HER-2 underexpression • PGR positive
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    Imfinzi (durvalumab) • paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • fulvestrant • Truqap (capivasertib) • anastrozole
    2d
    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
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive • HER-2 negative • HER-2 expression
    2d
    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)
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    HER-2 negative
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    everolimus • fulvestrant • exemestane • atirmociclib (PF-07220060)
    3d
    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
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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    ER positive • HER-2 negative • EGFR positive • EGFR negative
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    Oncotype DX Breast Recurrence Score®Test
    3d
    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
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
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    ER positive • PIK3CA mutation • PGR positive
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    Ibrance (palbociclib) • Piqray (alpelisib) • fulvestrant • gedatolisib (PF-05212384)
    3d
    ELEGANCE: Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia (clinicaltrials.gov)
    P=N/A, N=2766, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open
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    Kisqali (ribociclib) • letrozole • anastrozole
    3d
    CAPIcorn: Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment (clinicaltrials.gov)
    P3, N=250, Recruiting, West German Study Group
    New P3 trial • HEOR
    |
    Truqap (capivasertib)
    4d
    Anlotinib or Bevacizumab Combined with Taxane/Capecitabine for the Second-Line or Subsequent Treatment of HER-2 Negative Metastatic Breast Cancer: A Retrospective Cohort Study. (PubMed, Drug Des Devel Ther)
    This regimen was associated with improved DCR, PFS, and OS compared to bevacizumab plus chemotherapy in patients with HER2-negative MBC. These findings suggest that anlotinib may represent a promising therapeutic option for patients for whom ADC drugs are inaccessible or unsuitable; however, further prospective, randomized studies are warranted to confirm.
    Retrospective data • Journal
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
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    Avastin (bevacizumab) • Focus V (anlotinib) • capecitabine
    5d
    Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced or Metastatic Hormone Receptor(HR)-Positive and Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=8, Terminated, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=75 --> 8 | Trial completion date: Apr 2027 --> Nov 2025 | Recruiting --> Terminated | Trial primary completion date: Apr 2027 --> Nov 2025; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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    fulvestrant • Setanxin (culmerciclib)
    5d
    Real-world effectiveness of PARP inhibitors after CDK4/6 inhibitor therapy in BRCA-mutated HR-positive/HER2-negative advanced breast cancer. (PubMed, NPJ Breast Cancer)
    This benefit was confirmed in a multivariable analysis, supporting PARPi as the preferred option in eligible patients. Our findings suggest that PARPi should be prioritized in the post-CDK4/6i treatment sequence for BRCA LP/PV carriers with HR+/HER2 aBC and highlight the critical role of germline BRCA testing.
    Journal • Real-world evidence • BRCA Biomarker • PARP Biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
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    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative • BRCA mutation • HER-2 negative + HR positive + BRCA mutation