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    1m
    An open-label, single-arm, multicenter, phase II trial of bireociclib as monotherapy for heavily pretreated HR-positive, HER2-negative advanced breast cancer patients: BRIGHT-1 trial. (PubMed, Cancer Commun (Lond))
    Bireociclib monotherapy at 480 mg BID exhibited promising and sustained clinical activity, with no unexpected and acceptable toxicity in patients with recurrent or metastatic HR+/HER2- breast cancer who had progressed on or after previous therapy.
    P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    bireociclib (XZP 3287)
    7ms
    A Phase I/II Study of XZP-3287 in Metastasis Solid Tumors (clinicaltrials.gov)
    P1/2, N=402, Active, not recruiting, Sihuan Pharmaceutical Holdings Group Ltd. | Recruiting --> Active, not recruiting | N=300 --> 402 | Trial completion date: Dec 2022 --> Dec 2025
    Enrollment closed • Enrollment change • Trial completion date
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant • letrozole • anastrozole • bireociclib (XZP 3287)
    10ms
    BRIGHT-2: A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=300, Active, not recruiting, Xuanzhu Biopharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    fulvestrant • bireociclib (XZP 3287)
    over1year
    A multicenter, single-arm, open-label trial of birociclib, a CDK4/6 inhibitor, as a single agent, in patients with refractory HR+/HER2- metastatic breast cancer (ESMO 2023)
    The main results are shown in the table. Table: 404P Responses according to RECIST v1.1 Conclusions In patients with refractory HR+/HER2- MBC who have previously received chemotherapy and endocrine therapy, continuous dosing of single-agent birociclib exhibited promising and sustaining clinical activity with manageable toxicities, thus it provides an alternative orally single-agent therapy.
    Clinical • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    bireociclib (XZP 3287)
    almost2years
    A multicenter, single-arm, open-label trial of birociclib, a CDK4/6 inhibitor, as a single agent, in patients with refractory HR+/HER2- metastatic breast cancer. (ASCO 2023)
    In patients who have limited treatment options with refractory HR+/HER2- metastatic breast cancer, continuous dosing of single-agent Birociclib exhibited promising and sustaining clinical activity with acceptable safety profile, thus it provided an alternative orally administered therapy option. Clinical trial information: NCT04539496.
    Clinical • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    bireociclib (XZP 3287)
    3years
    A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=372, Not yet recruiting, Xuanzhu Biopharmaceutical Co., Ltd.
    New P3 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    letrozole • anastrozole • bireociclib (XZP 3287)
    3years
    A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=300, Recruiting, Xuanzhu Biopharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    fulvestrant • bireociclib (XZP 3287)
    over3years
    A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=300, Not yet recruiting, Xuanzhu Biopharmaceutical Co., Ltd.
    Clinical • New P3 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    fulvestrant • bireociclib (XZP 3287)
    over4years
    A Phase I/II Study of XZP-3287 in Metastasis Solid Tumors (clinicaltrials.gov)
    P1/2, N=300, Recruiting, Sihuan Pharmaceutical Holdings Group Ltd.
    Clinical • New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    bireociclib (XZP 3287)