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our Premium Content: News alerts, weekly reports and conference plannersBIOMARKER:
HER-2 negative + ER positive + ESR1 mutation
i
Other names: ERBB2, CD340, HER-2, HER2, NEU, NGL, V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2
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Entrez ID:
3d
Evaluating the investigational drug landscape for ESR1-mutated, estrogen receptor positive, HER2 negative metastatic breast cancer. (PubMed, Expert Opin Investig Drugs)
Routine assessment of ESR1 mutations using liquid biopsy should be integrated into clinical practice to enable dynamic, molecularly guided treatment optimization. The expanding arsenal of ER-targeted therapies supports personalized sequencing strategies that move beyond rigid temporal cutoffs and improve outcomes in ET resistant disease.
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 • ESR1 mutation • ER positive + HER-2 negative • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
2ms
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) (clinicaltrials.gov)
P3, N=315, Active, not recruiting, AstraZeneca | Trial completion date: Nov 2027 --> Sep 2028
Trial completion date • Circulating tumor DNA
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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ER positive • HR positive • HER-2 negative • ESR1 mutation • HR positive + HER-2 negative • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation • HER-2 negative + HR positive + ESR1 mutation
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Guardant360® CDx
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Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • letrozole • anastrozole • Etcamah (camizestrant) • goserelin acetate • leuprolide acetate for depot suspension
3ms
SUMIT-ELA: A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer (clinicaltrials.gov)
P1/2, N=49, Completed, Carrick Therapeutics Limited | Active, not recruiting --> Completed
Trial completion
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • CDK4 (Cyclin-dependent kinase 4)
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TP53 mutation • ER positive • HER-2 negative • ESR1 mutation • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
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Orserdu (elacestrant) • samuraciclib (CT7001)
4ms
FWD1802-001C: A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC. (clinicaltrials.gov)
P1/2, N=99, Recruiting, Forward Pharmaceuticals Co., Ltd. | Phase classification: P1 --> P1/2 | Trial completion date: Feb 2026 --> Mar 2028 | Trial primary completion date: Nov 2025 --> Mar 2026
Phase classification • Trial completion date • Trial primary completion date • First-in-human
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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 • ER positive + HER-2 negative • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
5ms
PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) (clinicaltrials.gov)
P2, N=297, Recruiting, Kristina A. Fanucci | Trial completion date: Oct 2029 --> Oct 2030 | Trial primary completion date: Dec 2028 --> Dec 2029
Trial completion date • Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CD4 (CD4 Molecule)
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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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capecitabine • Orserdu (elacestrant)
5ms
PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) (clinicaltrials.gov)
P2, N=297, Recruiting, Kristina A. Fanucci | Not yet recruiting --> Recruiting
Enrollment open
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CD4 (CD4 Molecule)
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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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capecitabine • Orserdu (elacestrant)
5ms
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC (clinicaltrials.gov)
P1/2, N=196, Recruiting, Forward Pharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open
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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 • ESR1 mutation • ER positive + HER-2 negative • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
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Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • Kisqali (ribociclib)
7ms
Real-World Outcomes of Elacestrant in ER+, HER2-, ESR1-mutant Metastatic Breast Cancer. (PubMed, Clin Cancer Res)
Elacestrant demonstrated durable benefit in real-world clinical practice, particularly in earlier lines and in patients with prolonged prior ET exposure. Despite coexisting ESR1 and PI3K-pathway mutations, TTNT remained clinically meaningful, reinforcing the role of elacestrant in personalized ET sequencing strategies prior to chemotherapy, antibody-drug conjugates, or targeted combinations.
Journal • Real-world evidence
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4)
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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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fulvestrant • Orserdu (elacestrant)
8ms
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) (clinicaltrials.gov)
P3, N=1050, Recruiting, Hoffmann-La Roche | Trial primary completion date: Jul 2026 --> Feb 2027
Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4)
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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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FoundationOne® Liquid CDx
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Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • giredestrant (RG6171)
10ms
A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer) (clinicaltrials.gov)
P3, N=373, Active, not recruiting, Genentech, Inc. | Trial primary completion date: Oct 2026 --> Jul 2025
Trial primary completion date
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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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everolimus • tamoxifen • fulvestrant • dexamethasone • exemestane • giredestrant (RG6171)
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