An Adjuvant Endocrine-Based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer
Primary:
- To demonstrate superiority of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of invasive breast cancer-free survival (IBCFS).
Secondary:
- To demonstrate superiority of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of invasive disease-free survival (IDFS).
- To demonstrate superiority of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of distant relapse-free survival (DRFS).
- To demonstrate superiority of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of overall survival (OS).
- To demonstrate superior tolerability of camizestrant ± abemaciclib as compared to
standard ET ± abemaciclib by assessment of the proportion of time on study treatment with high side-effect burden.
- To assess patient-reported treatment-associated symptoms of arthralgia, hot flush, and vaginal dryness of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib.
- To assess patient-reported health-related QoL in patients treated with camizestrant ± abemaciclib as compared to standard ET ± abemaciclib.
- To assess the steady-state PK of camizestrant in patients who received at least 1 dose of camizestrant per the protocol, for whom there is at least 1 reportable PK concentration.
Safety:
- To assess safety of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib.
ANASTROZOLE
Camizestrant
EXEMESTANE
LETROZOLE
TAMOXIFEN
- RWJBarnabas Health
- Community Medical Center
- Cooperman Barnabas, Livingston
- Jersey City Medical Center, Jersey City
- Monmouth Medical Center
- Monmouth Medical Center Southern Campus
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, Somerset
- Rutgers University
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.