^
    11ms
    Lerociclib plus fulvestrant in patients with HR+/HER2- locally advanced or metastatic breast cancer who have progressed on prior endocrine therapy: LEONARDA-1 a phase III randomized trial. (PubMed, Nat Commun)
    These findings support lerociclib plus fulvestrant as a treatment option for patients with HR+/HER2- endocrine-resistant advanced breast cancer (ABC). (Funded by Genor Biopharma; LEONARDA-1 ClinicalTrials.gov identifier, NCT05054751.).
    Clinical • P3 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    fulvestrant • lerociclib (G1T38)
    1year
    LEONARDA-1: GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=275, Completed, Genor Biopharma Co., Ltd. | Recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    fulvestrant • lerociclib (G1T38)
    almost2years
    A Study of Lerociclib in Participants With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=100, Terminated, EQRx, Inc. | Trial completion date: May 2026 --> Nov 2023 | Active, not recruiting --> Terminated; The study is being closed based on corporate changes at EQRx and is not related to any efficacy or safety issues with lerociclib.
    Trial completion date • Trial termination • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • PGR positive
    |
    fulvestrant • letrozole • lerociclib (G1T38)
    over2years
    A Study of Lerociclib in Participants With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=100, Active, not recruiting, EQRx, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • PGR positive
    |
    fulvestrant • letrozole • lerociclib (G1T38)
    over2years
    A Study of [14C]GB491 in Male Healthy Subjects (clinicaltrials.gov)
    P1, N=6, Completed, Genor Biopharma Co., Ltd.
    New P1 trial
    |
    lerociclib (G1T38)
    over2years
    A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=350, Recruiting, Genor Biopharma Co., Ltd.
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    letrozole • lerociclib (G1T38)
    over2years
    LEONARDA-1: Phase III randomized study of lerociclib plus fulvestrant in patients with HR+, HER2- locally advanced or metastatic breast cancer that has progressed on prior endocrine therapy. (ASCO 2023)
    Pre-/peri-menopausal pts also received goserelin. Lerociclib at 150mg twice daily plus fulvestrant significantly improved PFS and ORR and demonstrated a favorable tolerable safety profile in pts with HR+ / HER2- endocrine-resistant advanced BC. Clinical trial information: NCT05054751.
    Clinical • P3 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    fulvestrant • goserelin acetate • lerociclib (G1T38)
    almost3years
    G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=102, Active, not recruiting, G1 Therapeutics, Inc. | Trial completion date: Apr 2023 --> Oct 2023 | Trial primary completion date: Dec 2022 --> Jun 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant • lerociclib (G1T38)
    3years
    G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1b/2, N=30, Completed, G1 Therapeutics, Inc. | Active, not recruiting --> Completed | Trial completion date: Apr 2023 --> Feb 2022
    Trial completion • Trial completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M
    |
    Tagrisso (osimertinib) • lerociclib (G1T38)
    over3years
    G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=102, Active, not recruiting, G1 Therapeutics, Inc. | Trial completion date: Sep 2022 --> Apr 2023 | Trial primary completion date: Jul 2022 --> Dec 2022
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant • lerociclib (G1T38)
    over3years
    GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=270, Recruiting, Genor Biopharma Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    fulvestrant • lerociclib (G1T38)
    over3years
    A study to evaluate the safety and efficacy of Lerociclib in participants with advanced breast cancer (clinicaltrialsregister.eu)
    P2, N=100, Ongoing, EQRx, Inc.
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • PGR positive
    |
    lerociclib (G1T38)