Description:
The main purpose of this study is to measure how well LY3484356 works compared to hormone
therapy in participants with breast cancer that is estrogen receptor positive (ER+) and human
epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced
or has spread to another part of the body. Study participation could last up to 5 years.
Title
- Brief Title: Study of LY3484356 Versus Hormone Therapy, in Participants With Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Breast Cancer
- Official Title: EMBER-3: A Randomized, Open-Label, Phase 3 Study of LY3484356 vs Investigator's Choice of Endocrine Therapy, in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy
Clinical Trial IDs
- ORG STUDY ID:
18175
- SECONDARY ID:
J2J-OX-JZLC
- SECONDARY ID:
2021-000079-35
- NCT ID:
NCT04975308
Conditions
- Breast Neoplasms
- Neoplasm Metastasis
Interventions
Drug | Synonyms | Arms |
---|
LY3484356 | | LY3484356 |
Exemestane | | Investigator's Choice of Endocrine Therapy |
Fulvestrant | | Investigator's Choice of Endocrine Therapy |
Purpose
The main purpose of this study is to measure how well LY3484356 works compared to hormone
therapy in participants with breast cancer that is estrogen receptor positive (ER+) and human
epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced
or has spread to another part of the body. Study participation could last up to 5 years.
Trial Arms
Name | Type | Description | Interventions |
---|
LY3484356 | Experimental | LY3484356 administered orally. | |
Investigator's Choice of Endocrine Therapy | Active Comparator | Investigator's choice of exemestane administered orally or fulvestrant administered intramuscularly (IM). | |
Eligibility Criteria
- Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer
- 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.
- Must be deemed appropriate for treatment with endocrine therapy
- If female, have a postmenopausal status by natural or surgical means or by ovarian
function suppression
- Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only
disease)
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale
(Oken et al. 1982)
- Have adequate renal, hematologic, and hepatic organ function
- Must be able to swallow capsules/tablets
Exclusion Criteria:
- 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
- Have visceral crisis, lymphangitic spread within the lung, or any evidence of
leptomeningeal disease.
- Have symptomatic or untreated brain metastasis.
- Have serious preexisting medical conditions that, in the judgment of the investigator,
would preclude participation in this study
- Known allergic reaction against any of the components of the study treatment
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression Free Survival (PFS) |
Time Frame: | Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years) |
Safety Issue: | |
Description: | PFS by investigator assessment |
Secondary Outcome Measures
Measure: | Overall Survival (OS) |
Time Frame: | Randomization until death from any cause (estimated as up to 5 years) |
Safety Issue: | |
Description: | OS |
Measure: | Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) |
Time Frame: | Randomization until measured progressive disease (estimated as up to 1 year) |
Safety Issue: | |
Description: | ORR |
Measure: | Duration of Response (DoR) |
Time Frame: | Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years) |
Safety Issue: | |
Description: | DoR |
Measure: | Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (≥) 24 Weeks |
Time Frame: | Randomization until measured progressive disease (estimated as up to 1 year) |
Safety Issue: | |
Description: | CBR |
Measure: | PFS by Estrogen Receptor 1 Gene (ESR1) Mutation Status in Plasma |
Time Frame: | Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years) |
Safety Issue: | |
Description: | Investigator-assessed PFS by ESR1 mutation status in plasma |
Measure: | Progression Free Survival (PFS) |
Time Frame: | Randomization to the date of first documented progression of disease or death from any cause(estimated as up to 3 years) |
Safety Issue: | |
Description: | PFS by blinded independent review |
Measure: | Patient Reported Outcomes (PRO): Time to Worsening of "Worst Pain" |
Time Frame: | Screening through follow-up (estimated as up to 3 years) |
Safety Issue: | |
Description: | Measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single item, participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine." |
Measure: | Pharmacokinetics (PK): Steady State Plasma Concentrations of LY3484356 |
Time Frame: | Cycle 2 to Cycle 4 (cycle = 28 days) |
Safety Issue: | |
Description: | PK: steady state plasma concentrations of LY3484356 |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Eli Lilly and Company |
Trial Keywords
Last Updated
August 18, 2021