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.
LETROZOLE
- Rutgers Cancer Institute of New Jersey
- RWJBarnabas Health
- Newark Beth Israel Medical Center
- Rutgers Cancer Institute of New Jersey-University Hospital
Inclusion Criteria
- Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without
evidence of distant metastasis.
- Participants must have received at least 24 months but not more than 60 months of any
adjuvant ET, from time of adjuvant ET initiation.
- Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy
with a CDK4/6- or PARP- inhibitor.
- Must have an increased risk of disease recurrence based on clinical-pathological risk
features.
- Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
- Have adequate organ function.
Exclusion Criteria
- Have any evidence of metastatic disease (including contralateral ALN) or inflammatory
breast cancer at primary breast cancer diagnosis.
- Participants with more than a 6-month consecutive gap in therapy during the course of
prior adjuvant ET.
- Participants who have completed or discontinued prior adjuvant ET >6 months prior to
screening.
- Participants with a history of previous breast cancer are excluded, with the exception
of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.
- Pregnant, breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the screening visit through 180 days
after the last dose of study intervention.
- Participant has previously received ET of any duration for breast cancer prevention
(tamoxifen or AIs) or raloxifene.
- Participants with a history of any other cancer.
- Have serious preexisting medical conditions that, in the judgment of the investigator,
would preclude participation in this study.
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.