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

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.

Description

Eligibility

Age range

18–130 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Camizestrant

  Camizestrant. Experimental. Administered orally

• Drug
  Tamoxifen

  Tamoxifen. Comparator. Administered per local approved label

• Drug
  Anastrozole

  Anastrozole. Comparator. Administered per local approved label

• Drug
  Letrozole

  Letrozole. Comparator. Administered per local approved label

• Drug
  Exemestane

  Exemestane. Comparator. Administered per local approved label

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