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Camizestrant

DRUG19 trials

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
AstraZenecaAdditional Indications Below for Module 4 and 5, Biliary Cancer, Bladder Cancer +10
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
AstraZenecaHealthy Subjects
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
AstraZenecaHepatic Impairment
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
AstraZenecaER+ HER2- Advanced Breast Cancer, High-grade Serous Ovarian Cancer (HGSOC)
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
Astrazeneca ABPatients with ER+ HER2- advanced breast cancer and patients with high-grade serious ovarian cancer (HGSOC)
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
AstraZeneca ABAdvanced Solid Tumors
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
AstraZenecaHealthy Participants
Start: 2024-08-27End: 2025-08-20Updated: 2025-09-04

Phase 2

Phase 3

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
RecruitingNCT05774951
AstraZenecaBreast Cancer, Early Breast Cancer
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
Astrazeneca ABER+/HER2- Early Breast Cancer
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
AstraZenecaBreast Cancer, Early Breast Cancer
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
AstraZeneca ABER+/HER2- Early Breast Cancer
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
AstraZeneca ABEstrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
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
AstraZeneca ABEstrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
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
AstraZenecaAdvanced Breast Cancer
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
AstraZeneca ABEstrogen Receptor-Positive, HER-2 negative Advanced Breast Cancer
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
AstraZeneca ABEstrogen Receptor-Positive, HER-2 negative Advanced Breast Cancer
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
AstraZeneca ABAdvanced Breast Cancer
Start: 2025-04-07Target: 136Updated: 2025-12-29

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