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 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 eligible patients must have intermediate or high risk of recurrence, as defined by specified clinical and biologic criteria.
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy (CAMBRIA-1)
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
All genders
18+
Recruiting now
Overview
Principal Investigator: Rachel Buchsbaum, MD
Contact Us
Latoya Lashley
Study details
Inclusion Criteria
- 1. Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, 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. Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET
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 at 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
The planned duration of treatment in either arm of the study is 60 months. Patients will be followed for 10 years from randomization of the last patient. Patients will be randomised to one of the following arms: Arm A: Continue the standard ET of investigator’s choice Arm B: Camizestrant (150 mg, once daily) with or without LHRH agonist(s). Randomised patients will receive the assigned study treatment until diagnosis of an IBCFS event, completion of defined treatment period (60 months), patient withdrawal of consent, severe non-compliance with the Clinical Study Protocol (CSP), initiation of subsequent anti-cancer therapy, investigator determination that the patient is no longer benefiting from study treatment, pregnancy and intention to become pregnant, or study termination by AstraZeneca, whichever occurs first.