^
    12d
    CADILLAC: Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer (clinicaltrials.gov)
    P2, N=150, Recruiting, MedSIR | Not yet recruiting --> Recruiting | Initiation date: Dec 2025 --> Mar 2026
    Enrollment open • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Kisqali (ribociclib) • Etcamah (camizestrant)
    13d
    SERENA-1b: Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=24, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive
    |
    Etcamah (camizestrant) • atirmociclib (PF-07220060)
    2ms
    Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) (clinicaltrials.gov)
    P3, N=315, Active, not recruiting, AstraZeneca | Trial completion date: Nov 2027 --> Sep 2028
    Trial completion date • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HR positive • HER-2 negative • ESR1 mutation • HR positive + HER-2 negative • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation • HER-2 negative + HR positive + ESR1 mutation
    |
    Guardant360® CDx
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • letrozole • anastrozole • Etcamah (camizestrant) • goserelin acetate • leuprolide acetate for depot suspension
    3ms
    Identification, synthesis, and characterization of a unique N-glucuronide of an acid metabolite of camizestrant (AZD9833) in humans. (PubMed, Drug Metab Dispos)
    SIGNIFICANCE STATEMENT: Metabolite M14 of camizestrant (AZD9833), a major circulating metabolite in humans, was successfully identified as an N-glucuronide of an acid metabolite of camizestrant, and its unusual chromatographic and stability properties were characterized. The development of a novel hybrid chemical and biological synthesis for M14 has introduced a new approach to synthesizing glucuronides of compounds with acidic functional groups that otherwise interfere with their own in vitro glucuronidation.
    Journal
    |
    ER (Estrogen receptor)
    |
    ER positive
    |
    Etcamah (camizestrant)
    3ms
    MEDOPP0555: PHASE II STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CAMIZESTRANT PLUS RIBOCICLIB IN PATIENTS WITH HORMONE RECEPTOR-POSITIVE (HR+) BREAST CANCER? (THE CADILLAC STUDY) (2024-520027-88-00)
    P1/2, N=131, Recruiting, Medica Scientia Innovation Research S.L., Medica Scientia Innovation Research S.L. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Kisqali (ribociclib) • Etcamah (camizestrant)
    4ms
    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 | Trial completion date: Aug 2026 --> Aug 2027 | Trial primary completion date: Aug 2026 --> Aug 2027
    Trial completion date • Trial primary completion date • First-in-human
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • Etcamah (camizestrant)
    4ms
    SERENA-1b: Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=24, Not yet recruiting, AstraZeneca
    New P2 trial
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive
    |
    Etcamah (camizestrant) • atirmociclib (PF-07220060)
    4ms
    MEDOPP0555: PHASE II STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CAMIZESTRANT PLUS RIBOCICLIB IN PATIENTS WITH HORMONE RECEPTOR-POSITIVE (HR+) BREAST CANCER? (THE CADILLAC STUDY) (2024-520027-88-00)
    P1/2, N=131, Not yet recruiting, Medica Scientia Innovation Research S.L., Medica Scientia Innovation Research S.L.
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Kisqali (ribociclib) • Etcamah (camizestrant)
    4ms
    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
    |
    Etcamah (camizestrant)
    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: 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 • Etcamah (camizestrant)
    5ms
    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) • Etcamah (camizestrant)
    5ms
    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) • Etcamah (camizestrant)