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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
Relationship between overall survival and progression-free survival with 18 F-FDG PET/CT metabolic parameters in metastatic breast cancer patients treated with CDK 4/6 inhibitors. (PubMed, Ir J Med Sci)
Baseline 18 F-FDG PET/CT may provide prognostic insights in HR+/HER2- metastatic breast cancer. High MTV and TLG are associated with poorer OS in univariate analyses but not in multivariable analyses. ECOG score > 0 and age ≥ 60 years are independent predictors of PFS.
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
1d
Standardized Analytical Verification of ctDNA ESR1 Mutation Testing in Metastatic HR+/HER2- Breast Cancer: A European Multicentre Study Using dPCR and NGS-Based Liquid Biopsy. (PubMed, Mol Diagn Ther)
These results demonstrate that both dPCR and NGS-based liquid biopsy workflows can be successfully implemented for ESR1 mutation testing in routine clinical practice using locally validated assays. This multicentre verification study provides practical guidance on assay verification, DNA input requirements, and key analytical parameters required to ensure reliable ESR1 mutation detection across different European laboratories. Robust analytical verification of ESR1 testing may improve diagnostic reliability and support personalized treatment strategies for patients with hormone receptor-positive, HER2-negative metastatic breast cancer.
Journal • Liquid biopsy • Next-generation sequencing • Circulating tumor DNA
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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HR positive • HER-2 negative • HER-2 mutation • ESR1 mutation • HR positive + HER-2 negative • HER-2 negative + HR positive + ESR1 mutation
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Orserdu (elacestrant)
3d
Association between obesity and outcomes of first-line CDK4/6 inhibitor therapy in metastatic breast cancer: a multicenter real-world study. (PubMed, Sci Rep)
We retrospectively analyzed 332 patients with hormone receptor-positive/HER2-negative metastatic breast cancer who received first-line ribociclib or palbociclib plus endocrine therapy between 2018 and 2023. These findings suggest a potential association between BMI and clinical outcomes in this treatment setting. Prospective studies that integrate body composition and pharmacokinetics are required for validation.
Journal • Real-world evidence
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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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Ibrance (palbociclib) • Kisqali (ribociclib)
4d
Oncotype DX: Clinical Utility, Evidence, and Future Trends in Personalized Breast Cancer Management. (PubMed, Int J Cancer)
Ongoing research and technological advancements, such as artificial intelligence-based predictive models and novel biomarker identification, hold significant promise for further enhancing its predictive accuracy and expanding its applications. This review synthesizes current evidence supporting the clinical utility of Oncotype DX, discusses evolving applications, and highlights future directions for integrating this genomic tool into precision oncology practice.
Review • 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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Oncotype DX Breast Recurrence Score®Test
6d
Prevalence and Prognostic Implications of Circulating Tumor Cells Among Patients Undergoing Neoadjuvant Chemotherapy for Early-Stage Breast Cancer. (PubMed, Clin Breast Cancer)
CTCs are more prevalent both before and after NAC than had previously been reported. The clinical significance of their persistence warrants further investigation.
Journal • Circulating tumor cells
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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
Evaluating the Association of Ki-67 with Oncotype DX Recurrence Score in Early-Stage ER-Positive/HER2-Negative Breast Cancer. (PubMed, Cancers (Basel))
Overall concordance between Ki-67-based proliferation categories and RS-based genomic risk was 56.2%, with discordant cases in both directions. Ki-67 shows a modest association with Oncotype DX RS, but substantial discordance indicates Ki-67 should not substitute genomic testing in HR-positive/HER2-negative early breast cancer.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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HER-2 positive • ER positive • HR positive • HER-2 negative • HR positive + HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
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Oncotype DX Breast Recurrence Score®Test
7d
Annual report of national clinical database-breast cancer registry in 2023: systemic therapy for small breast cancer. (PubMed, Breast Cancer)
Among the 13,061 patients with pT1abN0M0 breast cancer, comprising 10,819 hormone receptor [HR]-positive/HER2-negative, 1479 HER2-positive and 763 HR-negative/HER2-negative individuals, 92.4% of HR-positive/HER2-negative patients received endocrine therapy, 46.9% of HER2-positive patients received chemotherapy and/or anti-HER2 therapy, and 31.2% of HR-negative/HER2-negative patients received chemotherapy. This annual report provides a nationwide overview of contemporary systemic therapy patterns in small breast cancer and highlights size‑dependent and subtype‑specific use of systemic therapy in Japan, reflecting a risk‑adapted treatment strategy.
Journal
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ER (Estrogen receptor) • PGR (Progesterone receptor)
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HER-2 positive • HR positive • HER-2 negative • EGFR positive • HR positive + HER-2 negative • HER-2 negative + HR negative
8d
First-line ET plus palbociclib versus standard mono-chemotherapy in high-risk HR-positive/HER2-negative metastatic breast cancer and indication for chemotherapy: primary results from the randomized phase IV PADMA study. (PubMed, ESMO Open)
PADMA is the first randomized multicenter study to show that palbociclib + ET as first-line treatment compared with CT also leads to improvements in TTF and PFS in predominantly postmenopausal patients with HR-positive/HER2-negative mBC.
Clinical • P4 data • Journal • BRCA 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)
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HER-2 positive • BRCA2 mutation • BRCA1 mutation • HR positive • HER-2 negative • EGFR positive • HR positive + HER-2 negative • HER-2 negative + HR positive + BRCA mutation
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Ibrance (palbociclib) • paclitaxel • capecitabine • epirubicin • vinorelbine tartrate
9d
Navigating first- and second-line treatment options in HR+HER2-negative advanced breast cancer. (PubMed, Oncologist)
In principle, the most effective and tolerable drugs should be used first with the goals of delaying chemotherapy and offering patients the best quality and duration of life. This review aims to explain the evolving treatment landscape for HR+HER2- advanced breast cancer and provides the scientific background for developing future treatment algorithms driven by preclinical and clinical results.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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HR positive • HER-2 negative • HR positive + HER-2 negative
10d
New perspectives on endocrine therapy suitability for hormone receptor-positive metastatic breast cancer in clinical practice. (PubMed, Breast)
We consider ET suitability to be the clinical assessment of whether a patient could benefit from ET, where benefit is defined not solely by tumor response but by a clinically relevant constellation of characteristics and markers possibly predicting the durability of disease response and symptom control. Several unresolved questions remain regarding issues such as disease heterogeneity, optimal treatment sequencing, and biomarker precision, but further work and ongoing studies will help to support the evolution of guidelines and provide clarity around the effective application of this quickly developing field to daily clinical practice.
Review • Journal
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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)
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HER-2 positive • HR positive • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative
10d
Meta-analysis reveals pathological complete response benefits from neoadjuvant immuno-chemotherapy combination in patients with HER2-negative breast cancer. (PubMed, BMC Cancer)
Immunotherapy showed substantial benefits in improving pCR rates in both TNBC and HR+HER2- patients when combined with neoadjuvant chemotherapy, especially in lymph node-positive breast cancer patients.
Retrospective data • Review • Journal
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
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HER-2 positive • HR positive • HER-2 negative • PD-L1 negative • HR positive + HER-2 negative
13d
A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=90, Recruiting, Cogent Biosciences, Inc. | Not yet recruiting --> Recruiting | Initiation date: Feb 2026 --> Jun 2026
Enrollment open • Trial initiation date
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HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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HER-2 positive • HR positive • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative