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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:
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
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
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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
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
6d
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
6d
Omission of sentinel lymph node biopsy in early stage luminal breast cancer: impact on adjuvant CDK4/6 inhibitor recommendation and oncological outcomes. (PubMed, Breast)
Omission of SLNB in patients with small HR-positive/HER2-negative tumors results in a missed indication for CDK4/6i in <8 % with minimal impact on recurrence.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HR positive • HER-2 negative • EGFR positive • HR positive + HER-2 negative
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Verzenio (abemaciclib) • Kisqali (ribociclib)
8d
Occult Breast Cancer Diagnosed from a Solitary Scalp Metastasis without Axillary Lymph Node Involvement: A Case Report. (PubMed, Surg Case Rep)
We report a rare case of OBC diagnosed based on a solitary scalp metastasis without ALNM. OBC without ALNM appears to favor luminal type and distinct metastatic sites, but further cases are needed to establish treatment strategies.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HR positive • HER-2 negative • HR positive + HER-2 negative
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anastrozole
8d
Cost-effectiveness analysis of first-line versus second-line use of CDK4/6 inhibitors combined with endocrine therapy in advanced HR+/HER2- breast cancer in China: based on the SONIA trial. (PubMed, Front Pharmacol)
This study supports the early use of CDK4/6 inhibitors combined with endocrine therapy as a cost-effective strategy for advanced HR+/HER2- breast cancer in China. Continued real-world monitoring is needed to adapt to changes in drug pricing and clinical practice.
Journal • HEOR • Cost-effectiveness
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HER-2 (Human epidermal growth factor receptor 2)
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HR positive • HER-2 negative • HR positive + HER-2 negative
8d
Breast surgery and systemic treatment continuation for patients with de novo metastatic breast cancer and locoregional oligoprogression: a cohort study. (PubMed, ESMO Open)
This study suggests that selected patients with de novo mBC and locoregional oligoprogression can benefit from breast surgery while maintaining the same systemic treatment, particularly in the setting of HER2-positive disease or a pre-oligoprogression PFS >1 year.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HR positive • HER-2 negative • EGFR positive • HR positive + HER-2 negative
9d
A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors (clinicaltrials.gov)
P1, N=168, Completed, AbbVie | Active, not recruiting --> Completed | Trial completion date: Jun 2025 --> Sep 2025 | Trial primary completion date: Jun 2025 --> Sep 2025
Trial completion • Trial completion date • Trial primary completion date • First-in-human
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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PD-L1 expression • HER-2 positive • EGFR mutation • HR positive • BRAF mutation • HER-2 negative • ALK mutation • ROS1 positive • HR positive + HER-2 negative
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paclitaxel • docetaxel • mirzotamab clezutoclax (ABBV-155)
9d
Retrospective review of metastatic hormone receptor-positive inflammatory breast cancer patients reveals poor responses to cyclin dependent kinase 4/6 inhibition. (PubMed, Breast Cancer Res)
Patients with metastatic HR+HER2- IBC demonstrated a shorter time on treatment suggesting shorter duration of response on CDKI + HT, which is markedly inferior to reported data for non-IBC patients from phase III trials.
Retrospective data • Journal
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR1 (Fibroblast growth factor receptor 1) • ARID1A (AT-rich interaction domain 1A) • CCND1 (Cyclin D1)
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HER-2 positive • TP53 mutation • HR positive • HER-2 negative • PIK3CA mutation • ARID1A mutation • ESR1 mutation • HR positive + HER-2 negative • HER-2 negative + HR positive + ESR1 mutation
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Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib)
9d
Cognitive function during endocrine treatment with or without cyclin-dependent kinase 4/6 inhibitors for advanced breast cancer. (PubMed, Cancer)
Patients with HR+HER2- ABC showed impaired cognitive function at initial diagnosis compared to cancer-free controls. During first-line endocrine treatment with aromatase inhibitors, cognitive function declined in a small group of patients, regardless of the addition of CDK4/6i.
Clinical • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HR positive • HER-2 negative • HR positive + HER-2 negative
14d
Enrollment change
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HER-2 (Human epidermal growth factor receptor 2) • FOLR1 ( Folate receptor alpha )
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HR positive • HER-2 negative • FOLR1 expression • HR positive + HER-2 negative
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Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • Rina-S (rinatabart sesutecan)
15d
Metformin enhances alpelisib sensitivity in HER2+ breast cancer by suppressing cancer stemness and oncogenic signaling. (PubMed, Front Oncol)
These findings indicate that metformin synergistically enhances the antitumor activity of alpelisib in HER2-positive breast cancer by inhibiting oncogenic signaling and stemness pathways. Beyond its metabolic benefit in mitigating hyperglycemia, metformin may potentiate PI3K-targeted therapies, supporting further preclinical and clinical evaluation of this combination strategy.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • CTNNB1 (Catenin (cadherin-associated protein), beta 1) • KLF4 (Kruppel-like factor 4) • SOX2 • ALDH1A1 (Aldehyde Dehydrogenase 1 Family Member A1) • NANOG (Nanog Homeobox)
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HER-2 positive • HR positive • HER-2 overexpression • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative • HER-2 overexpression + HR positive • HER-2 positive + HER-2 overexpression
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Piqray (alpelisib) • metformin