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    13h
    MONARCH plus: A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer (clinicaltrials.gov)
    P3, N=463, Active, not recruiting, Eli Lilly and Company | Trial completion date: Jan 2027 --> Mar 2028
    Trial 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 overexpression • HER-2 negative
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    Verzenio (abemaciclib) • fulvestrant • letrozole • anastrozole
    14h
    A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=180, Not yet recruiting, Shandong Suncadia Medicine Co., Ltd.
    New P1/2 trial
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    fulvestrant • letrozole
    23h
    SNV4818 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=320, Recruiting, Pikavation Therapeutics, Inc. | Phase classification: P1 --> P1/2 | N=140 --> 320 | Trial completion date: Dec 2026 --> Jun 2027 | Trial primary completion date: Oct 2026 --> Apr 2027
    Phase classification • Enrollment change • Trial completion date • Trial primary completion date
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    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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    PIK3CA mutation
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    Ibrance (palbociclib) • fulvestrant
    1d
    Evaluation of targeted and immune combination therapies in a rat model of hormone receptor-positive breast cancer. (PubMed, Proc Natl Acad Sci U S A)
    Here, we evaluated targeting candidates from this signature KMT5B/C and IKBKE using inhibitors A-196 and IKBKEi respectively, alongside anti-estrogen (fulvestrant) and a TGFβ blocking antibody (NIS793), both individually and in combination with αPD-L1, within this rat model. Comprehensive tumor profiling through polychromatic flow cytometry and single-cell RNA sequencing revealed that A-196 induced a luminal-to-basal shift in tumor epithelial cells, enhancing antigen presentation, whereas epithelial-to-mesenchymal transition was linked to fulvestrant resistance. Our findings underscore the value of the rat mammary tumor model for preclinical studies in ER-positive breast cancer and advocate for the further validation and potential clinical development of KMT5B/C inhibitors to enhance the efficacy and broaden the applicability of ICI therapy in cancer patients.
    Preclinical • Journal • PD(L)-1 Biomarker • IO biomarker
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    ER (Estrogen receptor) • TGFB1 (Transforming Growth Factor Beta 1) • IKBKE (Inhibitor Of Nuclear Factor Kappa B Kinase Subunit Epsilon)
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    ER positive • HR positive
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    fulvestrant • nisevokitug (NIS793)
    6d
    ‌A Phase II, Two-Stage Study Evaluating the Efficacy of Entinostat in Combined with Fulvestrant in Locally Advanced or Metastatic Breast Cancer with Recurrence or Progression after CDK4/6 Inhibitor plus Endocrine Therapy (ChiCTR2500114131)
    P=N/A, N=50, Not yet recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center
    New trial
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative
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    fulvestrant • Jingzhuda (entinostat)
    9d
    ELAINE 1: Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (clinicaltrials.gov)
    P2, N=100, Completed, Sermonix Pharmaceuticals Inc. | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> May 2025 | Trial primary completion date: Dec 2024 --> May 2025
    Trial completion • 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)
    |
    HER-2 negative • ESR1 mutation
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    fulvestrant • Fablyn (lasofoxifene)
    9d
    Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=28, Recruiting, The Methodist Hospital Research Institute | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Verzenio (abemaciclib) • fulvestrant
    10d
    optINAVO: To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Hoffmann-La Roche
    New P2 trial
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    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 negative • PIK3CA mutation
    |
    fulvestrant • Itovebi (inavolisib)
    10d
    Exploration of real-world outcomes in patients with previously treated HR+/HER2- and triple negative metastatic breast cancer. (PubMed, Sci Rep)
    Three HR+/HER2- mBC cohorts included 292 patients treated with palbociclib + fulvestrant, 274 patients treated with fulvestrant monotherapy, and 381 patients treated with paclitaxel-based therapy; the mTNBC cohort included 247 chemotherapy-treated patients. The alignment between several real-world and clinical trial endpoints is encouraging and supports the utility of real-world data in contextualizing outcomes, though interpretation may be influenced by data completeness and variability in clinical documentation. These insights are particularly relevant for populations with persistent unmet clinical needs.
    Journal • Real-world evidence
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 negative
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    Ibrance (palbociclib) • paclitaxel • fulvestrant
    10d
    Longitudinal Tumor Size and Survival Modeling for Exposure-Response Analysis of Drugs with Frequent Dose Reductions: Dose Justification of Abemaciclib in Patients with Metastatic Breast Cancer. (PubMed, Clin Pharmacol Ther)
    Simulations using the combined pharmacokinetic-tumor size-time to event model demonstrated the adequacy of a 150 mg twice daily dose in combination with fulvestrant. There was a negligible impact of dose reductions on efficacy, likely due to the shallow exposure-response relationship. When analyzing survival data where the drug exposure changes significantly within an individual over time, it is important to maximize the use of available longitudinal data through simultaneous modeling of time-course tumor size and survival data.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Verzenio (abemaciclib) • fulvestrant
    11d
    A Study of Single Dose of BL0175 in Postmenopausal Women (clinicaltrials.gov)
    P1, N=27, Not yet recruiting, Shanghai Best-Link Bioscience, LLC
    New P1 trial
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    fulvestrant
    11d
    A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread (clinicaltrials.gov)
    P1, N=198, Active, not recruiting, Eli Lilly and Company | Trial completion date: Dec 2025 --> Dec 2026
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • CDK4 (Cyclin-dependent kinase 4) • CDK6 (Cyclin-dependent kinase 6)
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    HR positive • HER-2 negative • EGFR positive
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    Herceptin (trastuzumab) • everolimus • tamoxifen • Perjeta (pertuzumab) • Verzenio (abemaciclib) • fulvestrant • letrozole • anastrozole • exemestane • samotolisib (LY3023414) • loperamide