EMBER-3: A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant plus Abemaciclib in Patients with ER+, HER2- Advanced Breast Cancer

JRCT ID: jRCT2051210102

Registered date:08/10/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Breast Neoplasms / Neoplasm Metastasis
• Date of first enrollment: 10/12/2021
• Target sample size: 860
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,China,Japan,Czech Republic,Japan,France,Japan,Germany,Japan,Greece,Japan,India,Japan,Italy,Japan,Mexico,Japan,Netherlands,Japan,Russia,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,Turkey,Japan,Ukraine,Japan,United State,Japan
• Study type: Interventional

Intervention(s)

Drug: Imlunestrant, Administered orally.
Drug: Exemestane, Administered orally.
Drug: Fulvestrant, Administered IM.
Drug: Abemaciclib, Administered orally.

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Masaki Takeshi
• Source(s) of Monetary Support: Eli Lilly and Company
• Secondary ID(s): NCT04975308