Breast Neoplasms / Neoplasm Metastasis
Conditions
Interventions
Drug: Imlunestrant, Administered orally.
Drug: Exemestane, Administered orally.
Drug: Fulvestrant, Administered IM.
Drug: Abemaciclib, Administered orally.
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer 2. Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor.(Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed) 3. Must be deemed appropriate for treatment with endocrine therapy 4. If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression 5. Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease) 6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982) 7. Have adequate renal, hematologic, and hepatic organ function 8. Must be able to swallow capsules/tablets
Exclusion criteria
Exclusion criteria: 1. Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor 2. Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease. 3. Have symptomatic or untreated brain metastasis. 4. Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study 5. Known allergic reaction against any of the components of the study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Progression Free Survival(PFS) in the Intent-to-Treat (ITT) Population PFS by investigator assessment in the ITT population 2.PFS in the Estrogen Receptor 1 (ESR1)-mutation Detected Population PFS by investigator assessment in ESR1-mutation detected population | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Greece, India, Italy, Japan, Mexico, Netherlands, Russia, South Korea, Spain, Taiwan, Turkey, Ukraine, United State
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed