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BIOMARKER:

HER-2 negative + ER positive

i
Other names: ERBB2, CD340, HER-2, HER2, NEU, NGL, V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2; ESR1, Era, ESR, NR3A1, ER, ER beta
Entrez ID:
Associations
1d
Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer (clinicaltrials.gov)
P2, N=27, Recruiting, Xijing Hospital | Trial primary completion date: Apr 2026 --> Dec 2026
Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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ER positive • HER-2 negative • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
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Loqtorzi (toripalimab-tpzi) • albumin-bound paclitaxel • cyclophosphamide • epirubicin
1d
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer (clinicaltrials.gov)
P2, N=40, Recruiting, University of Illinois at Chicago | Trial completion date: May 2026 --> May 2027 | Trial primary completion date: May 2026 --> May 2027
Trial completion date • Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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HER-2 positive • ER positive • HER-2 negative • HER-2 negative + ER positive
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MammaPrint® • EndoPredict®
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azacitidine
3d
Receptor discordance between primary tumors and nodal metastases and correlation with the 21-gene recurrence score in early-stage, estrogen receptor-positive, node-positive breast cancer. (PubMed, Breast Cancer Res Treat)
Receptor discordance between primary tumors and nodal metastases is common, with most shifts occurring within the HER2-spectrum. There was a trend toward higher RS and ER or HER2-receptor discordance. HER2 discordance was also associated with larger tumor size and larger size of nodal metastasis. As strategies emerge to target HER2-low cohorts and to include ER-low/HER2-negative disease within treatment regimens for TNBC, it may become important to consider receptor testing of nodal disease in the future.
Retrospective data • Journal
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ER (Estrogen receptor) • PGR (Progesterone receptor)
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HER-2 positive • ER positive • HER-2 negative • HER-2 negative + ER positive
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Oncotype DX Breast Recurrence Score®Test
6d
Distinguishing Ki67 stratification expression in ER-positive/HER2-negative breast cancers: comparison of advanced MRI diffusion models. (PubMed, BMC Med Imaging)
The FROC model could help identify the low Ki67 expression (≤ 5%) and prevent unnecessary chemotherapy.
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 • HER-2 negative • HER-2 expression • ER positive + HER-2 negative • HER-2 negative + ER positive
7d
Effects of short-course preoperative endocrine therapy on tumour morphology and immunohistochemical profile in oestrogen receptor-positive, HER2-negative breast cancer. (PubMed, Histopathology)
Short-course preoperative ET induces rapid and reproducible morphological and immunophenotypic changes in ER-positive, HER2-negative breast cancer. Ki67-defined response is associated with genomic risk and PR expression, whereas microenvironmental features appear to have limited predictive value.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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ER positive • HER-2 negative • HER-2 expression • ER positive + HER-2 negative • HER-2 negative + ER positive
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MammaPrint®
8d
Body mass index in postmenopausal women with estrogen receptor-positive, HER2-negative early breast cancer: An exploratory analysis of the LORELEI trial. (PubMed, Eur J Cancer)
Obesity was associated with lower ORR with letrozole alone, whereas this association was not observed in patients treated with taselisib.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • IL6 (Interleukin 6)
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HER-2 positive • ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
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letrozole • taselisib (GDC-0032)
8d
Prognosis of ER-positive, HER2-negative postmenopausal early breast cancer patients based on response to neoadjuvant endocrine therapy and multigene assay results: findings from the NEOS trial. (PubMed, Breast Cancer)
The need for chemotherapy in postmenopausal HR + , HER2- breast cancer patients might be further informed by integrating the results of the Oncotype DX test with the response to NET.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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ER positive • HER-2 negative • HER-2 negative + ER positive
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Oncotype DX Breast Recurrence Score®Test
9d
Breast 54: Focused Ultrasound and Gemcitabine in Breast Cancer (clinicaltrials.gov)
P1, N=32, Active, not recruiting, Patrick Dillon, MD | Recruiting --> Active, not recruiting
Enrollment closed
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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ER positive • HER-2 negative • HER-2 negative + ER positive
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MammaPrint®
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gemcitabine
9d
Leflunomide in Patients With PTEN-Altered Advanced Solid Malignancies and HER2 Negative Breast Cancer (clinicaltrials.gov)
P1, N=23, Recruiting, Deborah Doroshow | Trial completion date: Dec 2027 --> Jul 2028
Trial completion date
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PTEN (Phosphatase and tensin homolog)
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ER positive • HER-2 negative • PTEN deletion • PTEN mutation • HER-2 negative + ER positive
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leflunomide
10d
Trial completion date
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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HER-2 positive • ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
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fulvestrant • Etcamah (camizestrant)
13d
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
13d
New trial
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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ER positive • HER-2 negative • ESR1 mutation • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
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giredestrant (RG6171)