CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 4,300 target
Drug / intervention
Camizestrant +4 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Women and Men, age ≥18 years
  • ✓ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence
  • ✓Completed adequate locoregional therapy (surgery with or without radiotherapy) for primary breast tumor(s), with or without (neo)adjuvant chemotherapy
  • ✓Completed 2-5 years (+3 months) of adjuvant endocrine therapy (+/- CDK4/6 inhibitor)
Key exclusion· 12
  • ✕Inoperable locally advanced or metastatic breast cancer
  • ✕Pathological complete response following neoadjuvant therapy
  • ✕History of any other cancer unless in complete remission with no therapy for minimum 5 years
  • ✕Severe or uncontrolled systemic diseases precluding participation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

In the news

5 articles

Matched to this trial by ClinicalIndexfrom reputable biotech & medical press.

Search/NCT05774951
NCT05774951Phase 3RecruitingOn Track
Long Recruiting
CompareCT.gov

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

AstraZeneca·interventional·Posted Mar 20, 2023·Updated Jun 17, 2026

In Brief

A Phase 3 clinical trial evaluating Camizestrant, Tamoxifen, and 3 other interventions for Breast Cancer, Early Breast Cancer. Currently recruiting, targeting 4,300 participants across 709 sites in 39 countries.

Detailed Summary

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Early Breast Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Romania, Serbia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States, Vietnam
Collaborators--

Timeline

Phase 3Recruiting
20232024202520262027202820292030203120322033203420352036
First PostedMar 20, 2023
Enrollment StartMar 31, 2023
Primary CompletionApr 20, 2027
Study CompletionMay 29, 2036
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 3.3 years agoPrimary completion in 10 months

Arms & Interventions

Arm A: standard endocrine therapy of investigator´s choiceactive_comparator

Continue standard endocrine therapy of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen)

Drug: TamoxifenDrug: AnastrozoleDrug: LetrozoleDrug: Exemestane
Arm B: camizestrantexperimental

Camizestrant

Drug: Camizestrant

Interventions

Camizestrantdrug

Camizestrant. Experimental. Administered orally

Tamoxifendrug

Tamoxifen. Comparator. Administered per local approved label

Anastrozoledrug

Anastrozole. Comparator. Administered per local approved label

Letrozoledrug

Letrozole. Comparator. Administered per local approved label

Exemestanedrug

Exemestane. Comparator. Administered per local approved label