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

• Status: Recruiting
• Trial end date: 2037-05-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Austrian Breast and Colorectal Cancer Study Group (ABCSG)
• Treatments: Anastrozole; Exemestane; Letrozole; Tamoxifen

Criteria

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.