Breast Cancer
Conditions
Keywords
ELEGANT, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Female, Breast Cancer, Male, High-Risk Breast Cancer, High Risk Breast Carcinoma, ER-positive Breast Cancer, ER-positive HER-2 Negative Breast Cancer, ER Positive/HER2 Low Breast Cancer, Breast Cancer, ER+, HER2-, Adjuvant, Adjuvant Therapy
Brief summary
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
Interventions
DRUGElacestrant
Administered as oral tablets
DRUGAnastrozole
Administered as oral tablets
DRUGLetrozole
Administered as oral tablets
DRUGExemestane
Administered as oral tablets
DRUGTamoxifen
Administered as oral tablets
Sponsors
Stemline Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Histopathologically or cytologically confirmed ER+ (≥10% by immunohistochemistry \[IHC\]), HER2- (tumors with an IHC score of 0, 1+, or 2+ with in situ hybridization \[ISH\]-negative \[not amplified\]). ISH-negative without IHC testing will also be eligible 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/College of American Pathologists guidelines. * Participants must be node positive (microscopic and macroscopic tumor involvement are allowed) and fulfill one of the following criteria: 1. ≥4 positive axillary lymph nodes or 2. 1-3 positive axillary lymph nodes and 1. Histologic grade 3 disease and/or 2. Tumor size ≥5 centimeters and/or 3. High genomic risk (identified by Oncotype, MammaPrint, EndoPredict, PAM50) * Participants who are currently taking endocrine therapy (aromatase inhibitors or tamoxifen) and have received at least 24 months but not more than 60 months of endocrine therapy at the time of randomization (Cycle 1 Day 1 \[C1D1\]) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i) and with or without a luteinizing hormone-releasing hormone agonist. * Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase 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 non-breast 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 are off current adjuvant endocrine therapy more than 6 months prior to randomization. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Invasive Breast Cancer-Free Survival (IBCFS) | Up to 5 years | Assessed by the time from date of randomization to the date of first occurrence of: * Ipsilateral invasive breast tumor recurrence * Local/regional invasive breast cancer recurrence * Distant recurrence * Contralateral invasive breast cancer, or * Death attributable to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant Relapse-Free Survival (DRFS) | Up to 5 years | Assessed by the time from date of randomization to the date of first occurrence of: * Distant recurrence, or * Death attributable to any cause |
| Overall Survival (OS) | Up to 5 years | — |
| Invasive Disease-Free Survival (IDFS) | Up to 5 years | Assessed by the time from date of randomization to the date of first occurrence of: * Local/regional recurrence * Contralateral recurrence * Second primary non-breast invasive cancer * Distant recurrence, or * Death attributable to any cause |
| Number of Participants With Adverse Events (AEs) | Up to 5 years plus 28 days | — |
| 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) | Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5 | — |
| Change from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30 | Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5 | — |
| 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) | Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5 | — |
| 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) | Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5 | — |
| Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant | Predose up to 4 hours postdose | — |
| Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant | Predose up to 4 hours postdose | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Georgia, Germany, Hong Kong, Hungary, Italy, Malaysia, Netherlands, Poland, Portugal, Romania, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTStemline Trials
STUDY_DIRECTORMedical Director
Stemline Therapeutics, Inc.
Outcome results
None listed