^
    1d
    MiRaDoR: A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population (clinicaltrials.gov)
    P2, N=976, Recruiting, MedSIR | Trial completion date: Dec 2028 --> Jun 2028 | Trial primary completion date: Dec 2028 --> Jun 2028
    Trial completion date • Trial primary completion date • Minimal residual disease • Circulating tumor DNA
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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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    HR positive • HER-2 negative • HR positive + HER-2 negative
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • MammaPrint®
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    Verzenio (abemaciclib) • Itovebi (inavolisib) • giredestrant (RG6171)
    2d
    Chidamide combined with fulvestrant in the treatment of HR-positive, HER2-negative advanced breast cancer after failure of previous endocrine therapy: a single-arm, single-center, phase 2 study. (PubMed, Breast Cancer Res)
    Chidamide combined with fulvestrant showed encouraging antitumor activity and tolerable toxicity in pts with HR + /HER2- advanced breast cancer that had progressed after previous endocrine therapy. Trial registration ChiCTR2100044282, registered on March 14th 2021.
    P2 data • 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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    fulvestrant • Epidaza (chidamide)
    4d
    Targeting Semaphorin 7a signaling in preclinical models of endocrine therapy-resistant breast cancer. (PubMed, Mol Cancer Ther)
    Using mouse models of ER+BC (FVB/N mice, TC11 tumor model), we show reduced growth of SEMA7A+ tumors with PI3K inhibitors (GCT-007:10 mg/kg daily, alpelisib: 20mg/kg daily), alone or in combination with tamoxifen (0.5mg/100uL, every 3rd day). Combination of an anti-SEMA7A antibody (SmAbH1) (100-250 ug/100uL, every other day) and fulvestrant (83 mg/kg, every 5 days) also revealed that direct inhibition of SEMA7A via SmAbH1 significantly reduces tumor growth of SEMA7A-expressing tumors, and that the efficacy of SmAbH1 is not diminished by the standard of care, fulvestrant. Overall, our studies suggest that patients with ER+SEMA7A+ tumors should be candidates for PI3K-targeted therapies or anti-SEMA7A-based therapy.
    Preclinical • Journal
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    ER (Estrogen receptor) • SEMA7A (Semaphorin 7A)
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    ER positive
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    tamoxifen • Piqray (alpelisib) • fulvestrant
    6d
    Inavolisib-based Combination Therapy for the Treatment of PIK3CAMutated HR+/HER2- Breast Cancer: An Overview. (PubMed, Mini Rev Med Chem)
    Furthermore, it discusses the emerging resistance mechanisms to PI3K inhibition, mitigation of adverse effects, and future directions for inavolisib in personalized oncology. As studies continue to demonstrate its clinical utility, inavolisib exhibits preferential activity against the mutated PI3Kα isoform, thereby enhancing therapeutic specificity for combination therapy.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
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    Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)
    7d
    FALCON: A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer. (clinicaltrials.gov)
    P3, N=462, Completed, AstraZeneca | Trial completion date: Aug 2027 --> Jan 2026 | Active, not recruiting --> Completed
    Trial completion • Trial completion date
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    fulvestrant • anastrozole
    7d
    A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=61, Recruiting, Kind Pharmaceuticals LLC | Trial completion date: May 2026 --> Nov 2026 | Trial primary completion date: May 2026 --> Nov 2026
    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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    HER-2 negative
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    AND019
    9d
    Real-World Utilization of Palbociclib as First-Line Treatment for Canadian HR+/HER2- Women with Metastatic Breast Cancer: Results from PALCAN Study. (PubMed, Curr Oncol)
    The median duration of treatment for patients receiving an AI as an accompanying therapy was 15.1 (13.6-17.4) months and 7.9 months (5.8-12.6) for patients receiving fulvestrant, which may suggest endocrine resistance in the latter group. The PALCAN data provides insights into practice patterns and the effectiveness of palbociclib as a first-line therapy in female patients with HR+/HER2- breast cancer in the Canadian real-world setting.
    Journal • Real-world evidence
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
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    Ibrance (palbociclib) • fulvestrant
    11d
    Utilization and Safety of Concurrent Use of Abemaciclib and Radiation Therapy Among Patients With HR+, HER2- Metastatic Breast Cancer in the Real-World Setting. (PubMed, Adv Radiat Oncol)
    About half of the patients (47.7%) received abemaciclib in combination with fulvestrant, and 76.4% initiated abemaciclib at 150 mg twice daily. Most patients did not require a dose modification or interruption with concurrent RT and abemaciclib. These findings suggest that the addition of RT to abemaciclib therapy is well tolerated in patients with HR+, HER2- MBC.
    Journal • Real-world evidence
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    Verzenio (abemaciclib) • fulvestrant
    11d
    SERENA-1b: Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=24, Not yet recruiting, AstraZeneca
    New P2 trial
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive
    |
    camizestrant (AZD9833) • atirmociclib (PF-07220060)
    12d
    OP-1250-302: Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer (OPERA-02) (2025-522873-12-00)
    P2/3, N=312, Not yet recruiting, Olema Pharmaceuticals Inc.
    New P2/3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Kisqali (ribociclib) • letrozole • palazestrant (OP-1250)
    14d
    A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) (clinicaltrials.gov)
    P3, N=4170, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Mar 2026 --> Aug 2025
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    tamoxifen • giredestrant (RG6171)
    16d
    Overall Survival With First-Line vs Second-Line CDK4/6 Inhibitor Use in Advanced Breast Cancer: A Randomized Clinical Trial. (PubMed, JAMA Oncol)
    Aromatase inhibitor plus CDK4/6i as first-line treatment followed by fulvestrant as second-line treatment (CDK4/6i first-line group) vs aromatase inhibitor as first-line treatment followed by fulvestrant plus CDK4/6i as second-line treatment (CDK4/6i second-line group)...Post hoc analysis suggests an OS benefit with first-line use in premenopausal patients. ClinicalTrials.gov Identifier: NCT03425838.
    Clinical • Journal
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    HER-2 (Human epidermal growth factor receptor 2) • CDK4 (Cyclin-dependent kinase 4)
    |
    HR positive • HER-2 negative
    |
    fulvestrant