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

• Status: Not yet recruiting
• Trial end date: 2036-09-18
• Target enrollment: 0
• Participant gender: All

Summary

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 with intermediate or high risk for disease recurrence 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 planned duration of treatment in either arm of the study is 60 months.

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

Details

• Lead Sponsor: AstraZeneca
• 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 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

• Prior adjuvant therapy with CDK4/6 inhibitors for 2 years is allowed

• 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 >470 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