Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Elacestrant
Participants will receive 345 milligrams (mg) elacestrant once daily (QD) for 5 years
  • Drug: Elacestrant
    Administered as oral tablets
Experimental
Standard of Care (SoC) Endocrine Therapy
Participants will receive the SoC endocrine therapy that was used prior to randomization: - AI (anastrozole 1 mg QD, letrozole 2.5 mg QD, or exemestane 25 mg QD); or - Tamoxifen 20 mg QD
  • Drug: Anastrozole
    Administered as oral tablets
  • Drug: Letrozole
    Administered as oral tablets
  • Drug: Exemestane
    Administered as oral tablets
  • Drug: Tamoxifen
    Administered as oral tablets

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
Stemline Therapeutics, Inc.

Study Contact

Stemline Trials
1-877-332-7961
clinicaltrials@menarinistemline.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.