Clinical Trial 23572

• Overview

  Study 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 (ELEGANT)

  Objective:

  Primary Objective: * Evaluate the efficacy of elacestrant relative to standard endocrine therapy in terms of IBCFS in participants with node-positive, estrogen receptor-positive, HER2-negative early breast cancer with high risk of recurrence. Key Secondary Objectives: * Evaluate the efficacy of elacestrant relative to standard of care (SoC) in terms of distant relapse-free survival (DRFS). * Evaluate the efficacy of elacestrant relative to SoC in terms of overall survival (OS). Secondary Objectives: * Evaluate the efficacy of elacestrant relative to SoC in terms of invasive disease-free survival (IDFS). * Characterize the safety of elacestrant in the trial patient population. * Evaluate the effect of elacestrant relative to SoC on patient-reported outcomes (PROs). * Characterize elacestrant steady-state pharmacokinetics (PK) and exposure-response relationships (efficacy and safety)

• Treatments

  Therapies:

  Hormonal Therapy

  Medications:

  Anastrozole (); Arimadex (Anastrozole); Aromasin (Exemestane); Elacestrant (); Exemestane (); Femara (Letrozole); Letrozole (); Tamoxifen ()

• Inclusion 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.
  • Additional criteria may apply.

• Exclusion Criteria

  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.
  • Additional criteria may apply.

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