An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) - CAMBRIA-2

Study identifier:D8535C00001

ClinicalTrials.gov identifier:NCT05952557

EudraCT identifier:N/A

CTIS identifier:2023-504031-41

Recruiting

Official Title

CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease

Medical condition

Breast cancer, early breast cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Camizestrant, Tamoxifen, Anastrozole, Letrozole, Exemestane, Abemaciclib

Sex

All

Estimated Enrollment

5500

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 05 Oct 2023
Estimated Primary Completion Date: 04 Mar 2030
Estimated Study Completion Date: 06 May 2037

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Austrian Breast and Colorectal Cancer Study Group (ABCSG)

Inclusion and exclusion criteria