Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05514054 | A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 8,000 | — | — | Oct 4, 2022 | Mar 1, 2032 | Apr 2, 2026 | 672 | United States, Argentina +29 |
| NCT04975308 | A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 874 | — | — | Oct 4, 2021 | Aug 1, 2027 | Jul 11, 2025 | 243 | United States, Argentina +20 |
| NCT07287098 | A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer | PHASE2 | NOT YET_RECRUITING | 600 | — | — | May 1, 2026 | Dec 1, 2029 | May 22, 2026 | 60 | United States, Belgium +5 |
IDFS excluding second non-breast primary invasive cancers
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
| Arm | Type | Description |
|---|---|---|
| Imlunestrant | EXPERIMENTAL | Imlunestrant administered orally. |
| Investigator's Choice of Endocrine Therapy | ACTIVE_COMPARATOR | Investigator's choice of tamoxifen, anastrozole, letrozole, or exemestane administered per local approved label. |
| Arm A: Imlunestrant | EXPERIMENTAL | Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met. |
| Arm B: Investigator's Choice of Endocrine Therapy | EXPERIMENTAL | Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met. |
| Arm C: Imlunestrant + Abemaciclib | EXPERIMENTAL | Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met. |
| Cohort 1 Arm A | EXPERIMENTAL | Imlunestrant will be given orally |
| Cohort 1 Arm B - Imlunestrant + Goserelin | EXPERIMENTAL | Imlunestrant will be given orally and goserelin will be given subcutaneously (SC) |
| Cohort 1 Arm C - Tamoxifen | ACTIVE_COMPARATOR | Tamoxifen will be given orally |
| Cohort 2 Arm A - Imlunestrant | EXPERIMENTAL | Imlunestrant will be given orally |
| Cohort 2 Arm B - Tamoxifen | ACTIVE_COMPARATOR | Tamoxifen will be given orally |
| Name | Type | Description |
|---|---|---|
| Imlunestrant | DRUG | Administered orally. |
| Tamoxifen | DRUG | Administered per local approved label. |
| Anastrozole | DRUG | Administered per local approved label. |
| Letrozole | DRUG | Administered per local approved label. |
| Exemestane | DRUG | Administered per local approved label. |
| Fulvestrant | DRUG | Administered IM. |
| Abemaciclib | DRUG | Administered orally. |
| Goserelin | DRUG | Given SC |
| Tamoxifen 20 mg | DRUG | Given orally |
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 hav...