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

Purpose

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.

Condition

  • Breast Cancer, Early Breast Cancer

Eligibility

Eligible Ages
Between 18 Years and 130 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Women and Men; ≥18 years at the time of screening (or per national guidelines) - Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol. - Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy. - Patients must be randomised within 12 months of definitive breast surgery. - Patients may have received up to 12 weeks of endocrine therapy prior to randomisation. - Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 - Adequate organ and bone marrow function

Exclusion Criteria

  • Inoperable locally advanced or metastatic breast cancer - Pathological complete response following treatment with neoadjuvant therapy - 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 - Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance " - Known LVEF <50% with heart failure NYHA Grade ≥2. - Mean resting QTcF interval > 480 ms at screening - Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions - Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors ( eg, denosumab) - Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant - Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding. - Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists that would preclude the patient from receiving any LHRH agonist.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arm A: standard endocrine therapy of investigator´s choice ± abemaciclib
standard endocrine therapy of investigator's choice (aromatase inhibitors [AI; exemestane, letrozole, anastrozole] or tamoxifen) ± abemaciclib
  • 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
Experimental
Arm B: camizestrant ± abemaciclib
camizestrant ± abemaciclib
  • Drug: Camizestrant
    Camizestrant. Experimental. Administered orally
    Other names:
    • AZD9833
  • Drug: Abemaciclib
    Abemaciclib adjuvant treatment Administered orally

Recruiting Locations

Research Site
Nashville, Tennessee 37232

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed Description

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 of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.