Clinical Trials

Numerous clinical trials evaluate camizestrant (AZD9833) from early to late phases, focusing primarily on hormone receptor-positive, ER-positive, HER2-negative early and advanced breast cancer, solid tumors including ovarian, prostate, non-small cell lung, and colorectal cancers, and pharmacokinetic cohorts of healthy and hepatically impaired individuals. Sponsored by biopharmaceutical entities including AstraZeneca, Parexel, Quotient Sciences, and MedSIR, these studies encompass completed, active, recruiting, and non-recruiting trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05952557 ACTIVE_NOT_RECRUITING
Breast Cancer, Early Breast Cancer
AstraZeneca
 2023-10-05 PHASE3
NCT06380751 RECRUITING
Advanced Breast Cancer
AstraZeneca
 2024-08-01 PHASE3
NCT07647328 RECRUITING
ER-Positive HER2-Negative Breast Cancer
AstraZeneca
 2026-06-15 PHASE3
NCT07195227 RECRUITING
Hormon Receptor Positive Breast Cancer; Breast Cancer
MedSIR
 2026-03-24 PHASE2
NCT07427394 RECRUITING
Advanced Breast Cancer
AstraZeneca
 2026-05-06 PHASE2
NCT06188520 RECRUITING
ER+ HER2- Advanced Breast Cancer; High-grade Serous Ovarian Cancer (HGSOC)
AstraZeneca
 2023-12-05 PHASE1; PHASE2
NCT04644068 ACTIVE_NOT_RECRUITING
Ovarian Cancer; Breast Cancer; Pancreatic Cancer; Prostate Cancer; Additional Indications Below for Module 4 and 5; Non-small Cell Lung Cancer; Colorectal Cancer; Bladder Cancer; Gastric Cancer; Biliary Cancer; Cervical Cancer; Endometrial Cancer; Small Cell Lung Cancer Only in Module 5
AstraZeneca
 2020-11-12 PHASE1; PHASE2
NCT05774951 RECRUITING
Breast Cancer, Early Breast Cancer
AstraZeneca
 2023-03-31 PHASE3
NCT04711252 ACTIVE_NOT_RECRUITING
ER-Positive HER2-Negative Breast Cancer
AstraZeneca
 2021-01-28 PHASE3
NCT06547164 COMPLETED
Healthy Participants
AstraZeneca
 2024-08-27 PHASE1
NCT04964934 ACTIVE_NOT_RECRUITING
ER-Positive HER2-Negative Breast Cancer
AstraZeneca
 2021-06-30 PHASE3
NCT03616587 ACTIVE_NOT_RECRUITING
ER+ HER2- Advanced Breast Cancer
AstraZeneca
 2018-10-11 PHASE1
NCT05790304 COMPLETED
Hepatic Impairment
AstraZeneca
 2023-02-20 PHASE1
NCT04818632 COMPLETED
ER+, HER2-, Metastatic Breast Cancer
AstraZeneca
 2021-11-12 PHASE1
NCT04588298 COMPLETED
HER2-negative Breast Cancer
AstraZeneca
 2020-11-02 PHASE2
NCT05551897 COMPLETED
Healthy Subjects
AstraZeneca
 2022-10-04 PHASE1
NCT05438303 COMPLETED
Healthy Volunteers
AstraZeneca
 2022-06-13 PHASE1
NCT05551897 Completed
Healthy Subjects
AstraZeneca|Parexel
 2022-10-04 Phase 1
NCT04214288 ACTIVE_NOT_RECRUITING
Advanced ER-Positive HER2-Negative Breast Cancer
AstraZeneca
 2020-04-22 PHASE2
NCT04541433 COMPLETED
ER+ HER2- Advanced Breast Cancer
AstraZeneca
 2020-09-29 PHASE1
NCT05364255 COMPLETED
ER-positive, HER2-negative Breast Cancer
AstraZeneca
 2022-05-10 PHASE1
NCT05364255 Completed
ER-positive HER2-negative Breast Cancer
AstraZeneca|Quotient Sciences
 2022-05-10 Phase 1
NCT04546347 COMPLETED
Healthy Volunteers
AstraZeneca
 2020-09-17 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-10)

Check the Camizestrant (AZD9833) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Camizestrant (AZD9833) functions as an oral selective estrogen receptor degrader that binds directly to estrogen receptor alpha, triggering receptor degradation and blocking downstream estrogen-mediated transcriptional activation. This depletion of functional estrogen receptors suppresses hormone-driven cell proliferation, thereby limiting tumor progression in estrogen receptor-positive breast cancer and related endocrine-sensitive malignancies.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.