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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
130 Years
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.
Primary outcome measure(s)
Invasive breast cancer-free survival (IBCFS) — Up to 14 years IBCFS is defined as time from randomisation until date of first occurrence of:
* Invasive ipsilateral breast tumour recurrence
* Locoregional invasive breast cancer recurrence
* Distant recurrence
* Contralateral invasive breast cancer
* Death attributable to any cause.
Trial sites (661)
Facility
City
Region
Status
Research Site
Dothan
Alabama
Research Site
Phoenix
Arizona
Research Site
Tucson
Arizona
Research Site
Fayetteville
Arkansas
Research Site
Duarte
California
Research Site
Fountain Valley
California
Research Site
Irvine
California
Research Site
La Jolla
California
Research Site
Los Angeles
California
Research Site
Walnut Creek
California
Research Site
West Hollywood
California
Research Site
Aurora
Colorado
Research Site
Littleton
Colorado
Research Site
Littleton
Colorado
Research Site
New Haven
Connecticut
Research Site
Newark
Delaware
Research Site
Clearwater
Florida
Research Site
Fort Myers
Florida
Research Site
Gainesville
Florida
Research Site
Jacksonville
Florida
Research Site
Pembroke Pines
Florida
Research Site
Plantation
Florida
Research Site
Plantation
Florida
Research Site
St. Petersburg
Florida
Research Site
St. Petersburg
Florida
Research Site
Tallahassee
Florida
Research Site
West Palm Beach
Florida
Research Site
Atlanta
Georgia
Research Site
Marietta
Georgia
Research Site
Thomasville
Georgia
Research Site
Chicago
Illinois
Research Site
Elmhurst
Illinois
Research Site
Naperville
Illinois
Research Site
Urbana
Illinois
Research Site
Fort Wayne
Indiana
Research Site
Des Moines
Iowa
Research Site
Louisville
Kentucky
Research Site
New Orleans
Louisiana
Research Site
Scarborough
Maine
Research Site
Annapolis
Maryland
+ 621 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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