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NCT04541433
A Phase 1 Study of AZD9833 in Japanese Women With ER Positive, HER2 Negative Advanced Breast Cancer
Phase 1 trial testing AZD9833 in ER+ HER2- Advanced Breast Cancer in 10 participants. Completed in 23 June 2025.
29 July 2022
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 29 September 2020 |
| Primary completion | 29 July 2022 |
| Estimated completion | 23 June 2025 |
| Sites | 3 locations across Japan |
Drugs / interventions tested
- AZD9833 — full drug profile →
Conditions studied
- ER+ HER2- Advanced Breast Cancer — all drugs for ER+ HER2- Advanced Breast Cancer →
Sponsor
AstraZeneca — full company profile →
Who can join
Adults 20 to 130, female only, with ER+ HER2- Advanced Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 1, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AZD9833 in Japanese women with endocrineresistant ER+ HER2- breast cancer that is not amenable to treatment with curative intent. This study consists of 2 cohorts, Cohort1 and Cohort2. In cohort 1 (for tolerability evaluation), a minimum of 3, or up to 6, evaluable Japanese patients with ER+ HER2- breast cancer will be enrolled. In cohort 2 (for exploratory research), at least 6 to maximum 12 evaluable Japanese patients with ER+ HER2- breast cancer will be enrolled.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04541433
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AZD9833
Trials testing the same drug.
- NCT05438303 — Study to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celec · Phase 1 · completed
- NCT04818632 — AZD9833 China PK Study · Phase 1 · completed
- NCT04964934 — Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) · Phase 3 · active not recruiting
- NCT04711252 — A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Ne · Phase 3 · active not recruiting
- NCT04588298 — A Study to Investigate the Biological Effects of AZD9833 in Women With ER-positive, HER2 Negative Primary Breast Cancer · Phase 2 · completed
Other recruiting trials for ER+ HER2- Advanced Breast Cancer
Currently open trials in the same condition.
- NCT06188520 — A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Com · Phase 1, PHASE2 · recruiting
- NCT03616587 — Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer. · Phase 1 · active not recruiting
Other AstraZeneca trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04541433 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
- Last refreshed: 7 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04541433.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing