^
    1d
    Pharmacodynamics of Camizestrant Treatment in Postmenopausal Women With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Primary Breast Cancer: Results From the Randomized, Presurgical SERENA-3 Study. (PubMed, J Clin Oncol)
    SERENA-3 demonstrates that camizestrant 75 mg once daily (Phase III dose) is well-tolerated and achieves maximal reduction in ER through known mechanisms, that is, antagonism and degradation, by 5-7 days, and proliferation suppression determined by Ki67 expression, by 12-15 days. These data support camizestrant 75 mg once daily as the preferred dose for ongoing clinical development and highlight the importance of presurgical WOO studies in guiding dose selection.
    PK/PD data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • EGFR positive
    |
    camizestrant (AZD9833)
    6d
    SERENA-1: Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer. (clinicaltrials.gov)
    P1, N=396, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2026 --> Jun 2027
    Trial completion date • First-in-human
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • Kisqali (ribociclib) • Truqap (capivasertib) • anastrozole • camizestrant (AZD9833)
    12d
    Camizestrant in combination with capivasertib for women with ER-positive, HER2-negative advanced breast cancer: results from SERENA-1. (PubMed, ESMO Open)
    In these pretreated participants, camizestrant 75 mg in combination with capivasertib 400 mg was well tolerated, with a side effect profile consistent with each drug as monotherapy, and showed encouraging evidence of clinical efficacy.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    ER positive • HER-2 negative • EGFR positive • HER-2 negative + ER positive
    |
    fulvestrant • Truqap (capivasertib) • camizestrant (AZD9833)
    25d
    CYCAD-1: A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=564, Recruiting, AstraZeneca | N=348 --> 564
    Enrollment change • First-in-human
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • camizestrant (AZD9833)
    25d
    Selective Estrogen Receptor Degraders Induce Bradycardia by Modulating Nuclear Estrogen Signaling. (PubMed, JACC Basic Transl Sci)
    Giredestrant and camizestrant induced significant bradycardia in wild-type zebrafish embryos, whereas fulvestrant and amcenestrant (SERDs that do not induce bradycardia in patients) did not alter heart rate. Mutations in gper, esr2a, and esr2b did not confer resistance to SERD-induced bradycardia, whereas esr1 mutant embryos were protected. These findings demonstrate that SERD-associated bradycardia is mediated through Esr1 signaling, supporting an on-target adverse effect.
    Journal
    |
    ER (Estrogen receptor)
    |
    ER positive • BRAF wild-type • ESR1 mutation
    |
    fulvestrant • amcenestrant (SAR439859) • camizestrant (AZD9833) • giredestrant (RG6171)
    3ms
    Patient-reported outcomes in the SERENA-6 trial of camizestrant plus CDK4/6 inhibitor in patients with advanced breast cancer and emergent ESR1 mutations during first-line endocrine-based therapy. (PubMed, Ann Oncol)
    Together with the clinical efficacy and manageable safety profile of camizestrant-CDK4/6i, and reduced risk of GHS/QoL deterioration, the PROs from the SERENA-6 trial support switching to this combination as a potential new treatment strategy to optimise and improve outcomes in patients with HR+/HER2- advanced breast cancer and ESR1m emergence, ahead of disease progression, during first-line AI-CDK4/6i.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative • ESR1 mutation
    |
    camizestrant (AZD9833)
    4ms
    SERENA-1: Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer. (clinicaltrials.gov)
    P1, N=396, Active, not recruiting, AstraZeneca | Trial completion date: Nov 2025 --> Dec 2026
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • Kisqali (ribociclib) • Truqap (capivasertib) • anastrozole • camizestrant (AZD9833)
    4ms
    CADILLAC: Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer (clinicaltrials.gov)
    P2, N=150, Not yet recruiting, MedSIR
    New P2 trial
    |
    Kisqali (ribociclib) • camizestrant (AZD9833)
    5ms
    Switching ahead of progression: Insights from the SERENA-6 trial on targeting emerging ESR1 mutations in advanced HR+/HER2- breast cancer. (PubMed, Med)
    The phase 3 SERENA-6 trial showed that, in ER+/HER2- advanced breast cancer patients with emerging ESR1 mutations in ctDNA during aromatase inhibitor (AI) plus CDK4/6 inhibitor therapy, switching the AI to camizestrant significantly improved progression-free survival and delayed quality-of-life (QoL) deterioration.1 However, the clinical utility of early ctDNA-guided switching remains unconfirmed, as secondary endpoints (including PFS2 and overall survival) are still immature.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative • HER-2 mutation • ESR1 mutation
    |
    camizestrant (AZD9833)
    5ms
    A Study to Investigate the Pharmacokinetics of Midazolam After Repeated Doses of Camizestrant (AZD9833) and to Investigate the Pharmacokinetics of Camizestrant When Administered Alone and in Combination With Carbamazepine in Healthy Post-Menopausal Female Participants (clinicaltrials.gov)
    P1, N=40, Completed, AstraZeneca | Recruiting --> Completed
    Trial completion
    |
    camizestrant (AZD9833) • midazolam hydrochloride
    5ms
    PETRA: Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (clinicaltrials.gov)
    P1/2, N=702, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    carboplatin • paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • Datroway (datopotamab deruxtecan-dlnk) • camizestrant (AZD9833) • saruparib (AZD5305)
    5ms
    Positioning oral selective estrogen receptor degraders in patients with metastatic breast cancer. (PubMed, Eur J Cancer)
    Fulvestrant, the first selective estrogen receptor degrader (SERD) approved for clinical use, was developed to address this resistance and has remained the standard second-line endocrine therapy...The SERENA-6 trial demonstrated that early switching to the oral SERD camizestrant in patients with ESR1 mutation detected on ctDNA, prior to radiographic progression, significantly improved progression-free survival and patient-reported outcomes. However, whether molecular progression should routinely trigger treatment change remains an open question, requiring validation through long-term clinical endpoints. In conclusion, the integration of oral SERDs into current therapeutic algorithms poses clinical challenges, and ongoing trials will clarify their role across the disease continuum.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • ESR1 mutation
    |
    fulvestrant • camizestrant (AZD9833)