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A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence.

Primary Objective:
To evaluate the efficacy of imlunestrant (Arm A) vs SOC adjuvant ET (Arm B), in patients who have received 2 to 5 years of standard ET for ER+, HER2- EBC with an increased risk of recurrence.

Secondary Objectives:
- To evaluate the efficacy of Arm A compared to Arm B in terms of DRFS; OS, and IDFS, including second non-breast primary invasive cancers.

- To assess the safety and tolerability of each treatment arm.

- To assess the PK of imlunestrant.

- To describe health-related quality of life of each treatment arm.

- To describe patient-reported overall AE burden of each treatment arm.

Protocol Number: 042209
Phase: Phase III
Applicable Disease Sites: Breast
Drugs Involved: Imlunestrant
LETROZOLE
Principal Investigator: Mridula A George
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions:
  • RWJBarnabas Health
    • Community Medical Center
    • Jersey City Medical Center, Jersey City
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Newark Beth Israel Medical Center
    • Robert Wood Johnson University Hospital, Somerset
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.