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Trial Title:
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
NCT ID:
NCT06492616
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Recurrence
Tamoxifen
Letrozole
Anastrozole
Exemestane
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
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Elacestrant
Description:
Administered as oral tablets
Arm group label:
Elacestrant
Intervention type:
Drug
Intervention name:
Anastrozole
Description:
Administered as oral tablets
Arm group label:
Standard of Care (SoC) Endocrine Therapy
Intervention type:
Drug
Intervention name:
Letrozole
Description:
Administered as oral tablets
Arm group label:
Standard of Care (SoC) Endocrine Therapy
Intervention type:
Drug
Intervention name:
Exemestane
Description:
Administered as oral tablets
Arm group label:
Standard of Care (SoC) Endocrine Therapy
Intervention type:
Drug
Intervention name:
Tamoxifen
Description:
Administered as oral tablets
Arm group label:
Standard of Care (SoC) Endocrine Therapy
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mercy Medical Center
Address:
City:
Baltimore
Zip:
21202
Country:
United States
Status:
Recruiting
Investigator:
Last name:
David Riseberg
Email:
Principal Investigator
Start date:
September 27, 2024
Completion date:
October 2032
Lead sponsor:
Agency:
Stemline Therapeutics, Inc.
Agency class:
Other
Source:
Stemline Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06492616
