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

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) Versus 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

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Overview
Principal Investigator: Rachel Buchsbaum, MD

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).

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Latoya Lashley

Study details
Inclusion Criteria
  • 1. Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol.
  • 2. Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy.
  • 3. Patients must be randomised within 12 months of definitive breast surgery.
Exclusion Criteria
  • 1. Inoperable locally advanced or metastatic breast cancer
  • 2. Pathological complete response following treatment with neoadjuvant therapy
  • 3. History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered a very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation
Study Requirements

Patients will be randomised in a 1:1 ratio to one of the following arms: • Arm A: Standard ET of investigator's choice (aromatase inhibitors [AI; exemestane, letrozole, anastrozole] or tamoxifen) ± abemaciclib • Arm B: Camizestrant ± abemaciclib. The planned duration of treatment in either arm of the study is 7 years. Subjects will be followed for 10 years from randomization of the last patient.