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

Summary

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.

Conditions

• Breast Cancer, Early Breast Cancer

Interventions

DRUG

Camizestrant

Camizestrant. Experimental. Administered orally

DRUG

Tamoxifen

Tamoxifen. Comparator. Administered orally

DRUG

Anastrozole

Anastrozole. Comparator. Administered orally

DRUG

Letrozole

Letrozole. Comparator. Administered orally

DRUG

Exemestane

Exemestane. Comparator. Administered orally

DRUG

Abemaciclib

Abemaciclib adjuvant treatment Administered orally

Sponsors & Collaborators

• Austrian Breast and Colorectal Cancer Study Group (ABCSG)

  collaborator UNKNOWN

• AstraZeneca

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

130 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-05

Primary Completion

2030-03-04

Completion

2037-05-06

FDA Drug

Yes

Countries

• United States
• Argentina
• Australia
• Austria
• Belgium
• Brazil
• Bulgaria
• Canada
• Chile
• China
• Colombia
• Croatia
• Czechia
• Estonia
• France
• Georgia
• Germany
• Greece
• Hungary
• India
• Ireland
• Israel
• Italy
• Japan
• Malaysia
• Mexico
• New Zealand
• Peru
• Philippines
• Poland
• Portugal
• Puerto Rico
• Romania
• Saudi Arabia
• Serbia
• South Africa
• South Korea
• Spain
• Switzerland
• Taiwan
• Thailand
• Turkey (Türkiye)
• United Arab Emirates
• United Kingdom

Study Locations