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AZD9833

DRUG8 trials

Sponsors

AstraZeneca

Conditions

Advanced ER-Positive HER2-Negative Breast CancerER+ HER2- Advanced Breast CancerER+, HER2-, Metastatic Breast CancerER-Positive HER2-Negative Breast CancerHER2-negative Breast CancerHealthy Volunteers

Phase 1

Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer.
Active, not recruitingNCT03616587
AstraZenecaER+ HER2- Advanced Breast Cancer
Start: 2018-10-11End: 2027-06-24Updated: 2026-08-18
A Phase 1 Study of AZD9833 in Japanese Women With ER Positive, HER2 Negative Advanced Breast Cancer
CompletedNCT04541433
AstraZenecaER+ HER2- Advanced Breast Cancer
Start: 2020-09-29End: 2025-06-23Updated: 2025-08-07
AZD9833 China PK Study
CompletedNCT04818632
AstraZenecaER+, HER2-, Metastatic Breast Cancer
Start: 2021-11-12End: 2023-09-07Updated: 2024-12-17
Study to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celecoxib and of Dabigatran Etexilate in Healthy Postmenopausal Female Volunteers
CompletedNCT05438303
AstraZenecaHealthy Volunteers
Start: 2022-06-13End: 2022-12-13Updated: 2023-01-12

Phase 2

A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer
Active, not recruitingNCT04214288
AstraZenecaAdvanced ER-Positive HER2-Negative Breast Cancer
Start: 2020-04-22End: 2027-06-16Updated: 2026-08-26
A Study to Investigate the Biological Effects of AZD9833 in Women With ER-positive, HER2 Negative Primary Breast Cancer
CompletedNCT04588298
AstraZenecaHER2-negative Breast Cancer
Start: 2020-11-02End: 2023-06-19Updated: 2025-01-24

Phase 3

A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
Active, not recruitingNCT04711252
AstraZenecaER-Positive HER2-Negative Breast Cancer
Start: 2021-01-28End: 2029-02-01Updated: 2025-10-14
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
Active, not recruitingNCT04964934
AstraZenecaER-Positive HER2-Negative Breast Cancer
Start: 2021-06-30End: 2028-09-01Updated: 2026-07-14

Related Papers

SERENA-6 visual patient-reported outcomes & safety: camizestrant for emerging ESR1m advanced breast cancer during first-line endocrine-based therapy.
2026-07-24
Switching to camizestrant at ESR1 mutation emergence before disease progression during first-line treatment of hormone receptor-positive advanced breast cancer (SERENA-6): extended analysis of a double-blind, placebo-controlled, randomised, phase 3 trial.
2026-07-13
First-line (1L) camizestrant (CAMI) for emergent <i>ESR1</i> mutations ( <i>ESR1</i> m) in advanced breast cancer (ABC): Final progression-free survival 2 (PFS2) from the phase III SERENA-6 trial.
Journal of Clinical Oncology2026-06-03
Camizestrant in combination with capivasertib for women with ER-positive, HER2-negative advanced breast cancer: results from SERENA-1.
2026-01-21
Camizestrant in Combination with Three Globally Approved CDK4/6 Inhibitors in Women with ER+, HER2- Advanced Breast Cancer: Results from SERENA-1.
2025-10-011 citations
Estimating meaningful change thresholds (MCTs) for selected scales from the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires in the phase 3 SERENA-6 trial in patients with hormone receptor-positive/human epidermal growth factor receptor 2–negative advanced breast cancer (ABC).
JCO Oncology Practice2025-10-01
Abstract P5-06-17: The addition of ribociclib, palbociclib or abemaciclib to the next generation oral SERD, camizestrant, delivers greater anti-tumour efficacy in a range of ESR1wt and ESR1m breast PDX models
Clinical Cancer Research2025-06-13
Abstract PS7-08: Results from SERENA-1 Parts K/L: A Phase 1 study of the next-generation oral selective estrogen receptor degrader (SERD) camizestrant (AZD9833) in combination with ribociclib in women with ER-positive, HER2 negative advanced breast cancer
Clinical Cancer Research2025-06-13
Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent <i>ESR1</i> mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase 3, double-blind ctDNA-guided SERENA-6 trial.
Journal of Clinical Oncology2025-06-0414 citations
First-Line Camizestrant for Emerging <i>ESR1</i> -Mutated Advanced Breast Cancer
New England Journal of Medicine2025-06-0165 citations
CAMBRIA-1 &amp; CAMBRIA-2 phase III trials: camizestrant versus standard endocrine therapy in ER+/HER2– early breast cancer
Future Oncology2025-02-274 citations
Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): a multi-dose, open-label, randomised, phase 2 trial.
2024-11-0149 citations
heredERA Breast Cancer: a phase III, randomized, open-label study evaluating the efficacy and safety of giredestrant plus the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with previously untreated HER2-positive, estrogen receptor-positive locally advanced or metastatic breast cancer
BMC Cancer2024-05-246 citations
A phase I dose escalation and expansion trial of the next-generation oral SERD camizestrant in women with ER-positive, HER2-negative advanced breast cancer: SERENA-1 monotherapy results.
2024-05-0845 citations
Abstract RF01-01: SERENA-3: A randomized pre-surgical window of opportunity study assessing dose and duration of camizestrant treatment in post-menopausal women with ER-positive, HER2-negative primary breast cancer
Cancer Research2024-05-026 citations
Abstract PO3-19-09: SERENA-1: Results from a Phase 1 study (Parts I/J) testing the next-generation oral selective estrogen receptor degrader (SERD) camizestrant (AZD9833) in combination with capivasertib in women with ER+, HER2 advanced breast cancer
Cancer Research2024-05-025 citations
Abstract PS17-01: Key drivers of therapeutic response and resistance to giredestrant from GO39932: a Phase Ia/b study in patients with estrogen receptor-positive, HER2-negative, locally advanced or metastatic breast cancer
Cancer Research2024-05-021 citations
2MO Dynamics of ESR1 mutation (ESR1m) circulating tumour DNA (ctDNA) in patients (pts) with estrogen receptor (ER)+ HER2- metastatic breast cancer (mBC) receiving camizestrant or fulvestrant: Exploratory analyses from the SERENA-2 trial
ESMO Open2024-05-013 citations
AMEERA-4: a randomized, preoperative window-of-opportunity study of amcenestrant versus letrozole in early breast cancer.
2023-11-104 citations
Clinical activity of camizestrant, a next-generation SERD, versus fulvestrant in patients with a detectable <i>ESR1</i> mutation: Exploratory analysis of the SERENA-2 phase 2 trial.
Journal of Clinical Oncology2023-06-0119 citations

14 more papers not shown