Camizestrant
Sponsors
Astrazeneca AB, AstraZeneca AB, Medica Scientia Innovation Research S.L., Medica Scientia Innovation Research S.L., AstraZeneca, MedSIR
Conditions
Additional Indications Below for Module 4 and 5Advanced Breast CancerAdvanced Solid TumorsBiliary CancerBladder CancerBreast CancerBreast Cancer, Early Breast CancerCervical Cancer
Phase 1
Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies
Active, not recruitingNCT04644068
Start: 2020-11-12End: 2027-05-28Updated: 2026-02-19
A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole
CompletedNCT05551897
Start: 2022-10-04End: 2022-12-28Updated: 2023-01-06
Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects
CompletedNCT05790304
Start: 2023-02-20End: 2024-02-22Updated: 2025-03-25
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
RecruitingNCT06188520
Start: 2023-12-05End: 2027-08-04Target: 564Updated: 2026-02-24
A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants with Selected Advanced or Metastatic Solid Tumors (CYCAD-1)
RecruitingCTIS2023-507305-33-00
Start: 2024-04-29Target: 28Updated: 2026-01-22
A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies (PETRA)
Active, not recruitingCTIS2022-502856-29-00
Start: 2021-07-27Target: 427Updated: 2025-11-10
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
CompletedNCT06547164
Start: 2024-08-27End: 2025-08-20Updated: 2025-09-04
Phase 2
SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 versus Fulvestrant in Women with Advanced ER-Positive HER2-Negative Breast Cancer
Active, not recruitingCTIS2023-504974-40-00
Start: 2020-04-24Target: 30Updated: 2025-08-04
Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer
Not yet recruitingNCT07195227
Start: 2025-12-01End: 2028-03-31Target: 150Updated: 2025-10-02
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)
Not yet recruitingCTIS2024-520027-88-00
Target: 131Updated: 2026-01-20
Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer
Not yet recruitingNCT07427394
Start: 2026-04-10End: 2027-12-03Target: 24Updated: 2026-02-23
Phase 3
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
RecruitingNCT05774951
Start: 2023-03-31End: 2036-05-29Target: 4300Updated: 2026-02-25
CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients with ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence
RecruitingCTIS2022-501024-20-00
Start: 2023-07-25Target: 1242Updated: 2025-10-20
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
RecruitingNCT05952557
Start: 2023-10-05End: 2037-05-06Target: 5500Updated: 2025-06-19
CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease
RecruitingCTIS2023-504031-41-00
Start: 2024-03-25Target: 2049Updated: 2025-12-15
SERENA-4: A Randomised, Multicentre, Double-Blind, Phase 3 Study of AZD9833 (an Oral SERD) plus Palbociclib versus Anastrazole plus Palbociclib for the Treatment of Patients with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
Active, not recruitingCTIS2023-503995-26-00
Start: 2021-05-11Target: 499Updated: 2025-12-15
SERENA-4: A Randomised, Multicentre, Double-Blind, Phase 3 Study of AZD9833 (an Oral SERD) plus Palbociclib versus Anastrazole plus Palbociclib for the Treatment of Patients with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
Active, not recruitingCTIS2023-503995-26-00
Start: 2021-05-11Target: 499Updated: 2025-12-15
Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
RecruitingNCT06380751
Start: 2024-08-01End: 2030-10-18Target: 500Updated: 2026-03-12
SERENA-6: A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole) + CDK4/6 Inhibitor in HR+/HER2- MBC Patients with Detectable ESR1 Mutation Without Disease Progression During 1L Treatment with Aromatase Inhibitor + CDK4/6 Inhibitor A ctDNA Guided Early Switch Study
Active, not recruitingCTIS2023-503990-39-00
Start: 2021-09-30Target: 128Updated: 2025-09-24
SERENA-6: A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole) + CDK4/6 Inhibitor in HR+/HER2- MBC Patients with Detectable ESR1 Mutation Without Disease Progression During 1L Treatment with Aromatase Inhibitor + CDK4/6 Inhibitor A ctDNA Guided Early Switch Study
Active, not recruitingCTIS2023-503990-39-00
Start: 2021-09-30Target: 128Updated: 2025-09-24
A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant compared with Physician’s Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients with BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH non-amplified) Advanced Breast Cancer (EvoPAR-Breast01).
RecruitingCTIS2023-504180-16-00
Start: 2025-04-07Target: 136Updated: 2025-12-29