A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
Type of trial
Interventional
(ICTRP)
Intervention under investigation
Drug: ElacestrantDrug: AnastrozoleDrug: LetrozoleDrug: ExemestaneDrug: Tamoxifen
(ICTRP)
Disease under investigation
Breast Cancer
(ICTRP)
Key Inclusion Criteria:
- Histopathologically or cytologically confirmed ER-positive (= 10% by
immunohistochemistry [IHC]), HER2-negative [IHC = 0 or 1, or (IHC = 2 and in situ
hybridization [ISH]-negative)] on tumor biopsy or final surgical pathology specimen
early stage resected invasive breast cancer without evidence of recurrence or
distant metastases, per local laboratory, according to the American Society of
Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
- Participants considered at high risk of recurrence at initial staging
- Participants who have received at least 24 months but not more than 60 months of
endocrine therapy (AIs or tamoxifen) with or without a CDK 4 and CKD 6 inhibitor
(CDK4/6i)
- Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose
polymerase (PARP) inhibitor must have already completed or discontinued these
treatments.
Key Exclusion Criteria:
- Participants with inflammatory breast cancer
- History of any prior (ipsilateral and/or contralateral) invasive breast cancer
- Participant with history of malignancy within 3 years of the date of randomization,
except for adequately treated basal or squamous cell skin cancer, superficial
bladder cancer or carcinoma in situ of the cervix
- Participants who have had more than a 6-month continuous interruption of prior SoC
adjuvant endocrine therapy or who discontinued adjuvant endocrine therapy more than
6 months prior to randomization
Note: Other protocol defined Inclusion/Exclusion criteria may apply. (ICTRP)
Exclusion criteria
not available
Trial sites
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, , Denmark, France, Germany, Hong Kong, Hungary, Italy, Malaysia, Netherlands, Poland, Portugal, Romania, Singapore, , Spain, Switzerland, Taiwan, , United Kingdom
(ICTRP)
Academic title
Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Primary and secondary end points
Invasive Breast Cancer-Free Survival (IBCFS) (ICTRP)
Distant Relapse-Free Survival (DRFS);Overall Survival (OS);Invasive Disease-Free Survival (IDFS);Number of Participants With Adverse Events (AEs);Change from Baseline in Global Health Status Quality of Life Scale score, as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30);Change from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30;Change From Baseline in the Breast Cancer Endocrine Therapy Symptoms Sub-Scale Score, as Assessed by the EORTC Quality of Life Breast Cancer Questionnaire module (EORTC QLQ-BR42);Change From Baseline in Side Effects, as Assessed by the Question 168 of the European Organization for the Research and Treatment of Cancer Question Library (EORTC Q168);Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant;Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Medical DirectorStemline Trials, clinicaltrials@menarinistemline.com, 1-877-332-7961, Stemline Therapeutics, Inc. (ICTRP)
Secondary trial IDs
2024-515445-42-00, STML-ELA-0422 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT06492616 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available