^
    7d
    Cyclin-Dependent Kinase 4/6 Inhibitor in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer: Global Challenges and Tibremciclib Perspective. (PubMed, JCO Glob Oncol)
    Tibremciclib shows promise as an additional CDK4/6 inhibitor; however, its global integration requires broader, more diverse clinical trials, robust safety and survival data, and strategies to mitigate toxicity risks. Bridging access gaps will require coordinated efforts across policy, infrastructure, and global partnerships to ensure equitable benefit from emerging therapies.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • EGFR positive
    |
    Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • Konmana (tibremciclib)
    4ms
    Tibremciclib or Placebo Plus Fulvestrant in Hormone Receptor-Positive and ERBB2-Negative Advanced Breast Cancer After Endocrine Therapy: A Randomized Clinical Trial. (PubMed, JAMA Oncol)
    Furthermore, tibremciclib plus fulvestrant demonstrated a manageable safety profile in patients with HR+/ERBB2- ABC who experienced progression while receiving prior ET. ClinicalTrials.gov Identifier: NCT05433480.
    Clinical • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant • Konmana (tibremciclib)
    7ms
    A phase I dose-escalation and dose-expansion study of tibremciclib, a novel CDK4/6 inhibitor, monotherapy and in combination with fulvestrant in HR-positive/HER2-negative advanced breast cancer. (PubMed, ESMO Open)
    Tibremciclib monotherapy or combined with fulvestrant was well tolerated with the RP2D set at 400 mg plus fulvestrant 500 mg. PK was consistent with dose proportionality. Both regimens showed preliminary antitumor activity in patients with HR-positive/HER2-negative ABC, supporting further evaluation in a phase III study (NCT05433480).
    P1 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    fulvestrant • Konmana (tibremciclib)
    11ms
    A Phase I Study of BPI-16350 in Patients with Advanced Solid Tumor (clinicaltrials.gov)
    P1, N=54, Active, not recruiting, Betta Pharmaceuticals Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Konmana (tibremciclib)
    1year
    A Single-center, Open-label, Fixed-sequence, Drug-Drug Interaction Study of BPI-16350 co-administered with Rifampin or Itraconazole in Healthy Volunteers (ChiCTR2400090190)
    P1, N=36, Completed, Beijing Friendship Hospital ,Capital Medical University; Beijing Friendship Hospital ,Capital Medical University
    New P1 trial
    |
    itraconazole • Konmana (tibremciclib) • rifampicin
    over2years
    A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=274, Active, not recruiting, Betta Pharmaceuticals Co., Ltd. | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant • Konmana (tibremciclib)
    over3years
    A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=267, Not yet recruiting, Betta Pharmaceuticals Co., Ltd.
    New P3 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant • Konmana (tibremciclib)