Breast Cancer, Early Breast Cancer
Conditions
Interventions
arm A: continue with SoC ET as directed by investigator until treatment discontinuation. Pre- or peri-menopausal female or male patients in the Arm A receiving standard ET (AI or tamoxifen) should rec
Sponsors
Hibi Kazushige
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Women and Men, greater than or equal to 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) - Prior adjuvant therapy with CDK4/6 inhibitors for 2 years is allowed - Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1 - Adequate organ and marrow function
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Invasive breast cancer-free survival (IBCFS) [ Time Frame: Up to 10 years ] IBCFS is defined as time from randomisation until date of first occurrence of: - Invasive ipsilateral breast tumour recurrence (invasive IBTR) - Locoregional invasive breast cancer recurrence - Distant recurrence - Invasive contralateral breast cancer - Death attributable to any cause. | — |
Countries
Czech Republic, France, Georgia, Germany, Hellenic Republic, Hungary, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Portuguese Republic, Republic of Serbia, Romania, Singapore, South Africa, Spain, State of Israel, Taiwan, Thailand, Turkey, United Kingdom, United states of America, Viet Nam
Contacts
Public ContactKazushige Hibi
Astrazeneca K.K
Outcome results
None listed