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A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT05774951.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
Florida
Gainesville
University of Florida Health Science Center - Gainesville
Status: Active
Name Not Available
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Active
Name Not Available
Kentucky
Lexington
University of Kentucky/Markey Cancer Center
Status: Active
Name Not Available
New York
Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Name Not Available
New York
Mount Sinai West
Status: Active
Name Not Available
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available
Mount Sinai Chelsea
Status: Active
Name Not Available
North Carolina
Durham
Duke University Medical Center
Status: Active
Name Not Available
Raleigh
UNC Rex Healthcare
Status: Active
Name Not Available
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Name Not Available
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
Tennessee
Nashville
Vanderbilt University/Ingram Cancer Center
Status: Active
Name Not Available
Texas
Houston
Ben Taub General Hospital
Status: Active
Name Not Available
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Status: Active
Name Not Available
Wisconsin
Madison
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
