Breast Neoplasms
Conditions
Brief summary
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.
Interventions
DRUGImlunestrant
Administered orally.
DRUGTamoxifen
Administered per local approved label.
DRUGAnastrozole
Administered per local approved label.
DRUGLetrozole
Administered per local approved label.
DRUGExemestane
Administered per local approved label.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Invasive Disease-Free Survival (IDFS) | Randomization to recurrence or death from any cause (up to 10 years) | IDFS excluding second non-breast primary invasive cancers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant Recurrence-Free Survival (DRFS) | Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years) | DRFS |
| Overall Survival (OS) | Randomization to Death from Any Cause (up to 10 Years) | OS |
| Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant | Year 1, Month 2 to Month 4 | PK: steady state plasma concentrations of imlunestrant |
| Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning | Visit 1 Day 1 up to end of Year 5 | The EORTC QLQ-C30 is a 30-question patient reported instrument used to assess multidimensional quality of life (QOL) in cancer patients. It consists of 15 domains: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). Physical functioning was measured by items 1 to 5. The sum score was linearly transformed to the range 0 - 100 as recommended by the EORTC (higher score is better). |
| Change from Baseline in the EORTC QLQ-C30 Role Functioning | Visit 1 Day 1 up to end of Year 5 | The EORTC QLQ-C30 is a 30-question patient reported instrument used to assess the multidimensional QOL in cancer patients. It consists of 15 domains: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). Role functioning was measured by items 6 and 7. The sum score was linearly transformed to the range 0 - 100 as recommended by the EORTC (higher score is better). |
| Change from Baseline in the EORTC QLQ-C30 Global QOL | Visit 1 Day 1 up to end of Year 5 | The EORTC QLQ-C30 is a 30-question patient reported instrument used to assess the multidimensional QOL in cancer patients. It consists of 15 domains: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). Global QOL was measured by items 29 and 30. The sum score was linearly transformed to the range 0 - 100 as recommended by the EORTC (higher score is better). |
| Proportion of Time on Study Treatment with High Overall Adverse Event Burden | Visit 1 Day 1 up to end of Year 5 | FACT GP5 = Functional Assessment of Cancer Therapy - General Physical Well-being Item 5 (FACT GP5). High overall adverse event burden is defined as a score of 3 or 4 on a 5-point Likert scale. Higher scores represent higher symptom burden. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Romania, Singapore, Slovakia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed