A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy - CAMBRIA-1

Study identifier:D8531C00002

ClinicalTrials.gov identifier:NCT05774951

EudraCT identifier:N/A

CTIS identifier:2022-501024-20-00

Recruiting

Official Title

A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients with ER+/HER2- Early Breast Cancer

Medical condition

Breast cancer, early breast cancer

Phase

Phase 3

Healthy volunteers

Study drug

Camizestrant, Tamoxifen, Anastrozole, Letrozole, Exemestane

Sex

All

Estimated Enrollment

4300

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 31 Mar 2023

Estimated Primary Completion Date: 19 Apr 2027

Estimated Study Completion Date: 29 May 2036

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2024 by AstraZeneca

Collaborators

Inclusion and exclusion 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 high or intermediate risk of recurrence, based on clinical-pathological risk features, 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
• Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
• Adequate organ and 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 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
• 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

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Arms	Assigned Interventions
Active Comparator: Arm A: standard endocrine therapy of investigator´s choice Continue standard endocrine therapy of investigator’s choice (aromatase inhibitors [AI; exemestane, letrozole, anastrozole] or tamoxifen)	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
Experimental: Arm B: camizestrant Camizestrant	Drug: Camizestrant Camizestrant. Experimental. Administered orally Other Name: AZD9833

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]