Camizestrant History and Updates

33 events · 2020 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
33
Trial Milestones
0
Pivotal Publications
Camizestrant — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2021202220232024202520262027202820292030Trial: NCT07427394 2026-04-10 → 2027-12-03 (primary completion)Trial: NCT07195227 2025-12-01 → 2028-02-29 (primary completion)Trial: NCT06547164 2024-08-27 → 2025-08-20 (primary completion)Trial: NCT06380751 2024-08-01 → 2029-03-30 (primary completion)Trial: NCT06188520 2023-12-05 → 2027-08-04 (primary completion)Trial: NCT05952557 2023-10-05 → 2030-03-04 (primary completion)Trial: NCT05774951 2023-03-31 → 2027-04-20 (primary completion)Trial: NCT05790304 2023-02-20 → 2024-02-22 (primary completion)Trial: NCT05551897 2022-10-04 → 2022-12-28 (primary completion)Trial: NCT04644068 2020-11-12 → 2027-05-28 (primary completion)today (2026-07-15)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-07-15Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Camizestrant since 2020, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT05774951
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
Primary completion· ClinicalTrials.gov
Phase 1/Phase 2 primary completion: NCT06188520
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Particip
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07427394
Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07647328
A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07647328
A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06380751
Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negati
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT05952557
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

Past events

2026
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07427394
Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer
2025
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06547164
A Study to Investigate the Pharmacokinetics of Midazolam After Repeated Doses of Camizestrant (AZD9833) and to Investigate the Pharmacokinet
2024
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06547164
A Study to Investigate the Pharmacokinetics of Midazolam After Repeated Doses of Camizestrant (AZD9833) and to Investigate the Pharmacokinet
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06380751
Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negati
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05790304
Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects
2023
Trial started· ClinicalTrials.gov
Phase 1/Phase 2 trial started: NCT06188520
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Particip
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05952557
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05774951
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05790304
Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects
2022
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05551897
A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05551897
A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole
2020

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.