Breast Neoplasms, Neoplasm Metastasis
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 CDK4/6 inhibitor. oPatients are expected to have received prior treatment with a CDK4/6 inhibitor if this treatment is approved and can be reimbursed · 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To compare the PFS of imlunestrant (Arm A) to the standard comparator of Investigator’s Choice Endocrine Therapy of either fulvestrant or exemestane (Arm B) in the ITT population •To compare the PFS of Arm A to Arm B in the ESR1-mutation detected population •To To compare the PFS of imlunestrant plus abemaciclib (Arm C) to imlunestrant (Arm A) in the ITT population ;Secondary Objective: •To compare OS of Arm A to Arm B in the ITT population •To compare OS of Arm A to Arm B in the ESR1-mutation detected population •To compare OS of Arm C to Arm A in the ITT population •To assess the safety and tolerability of each treatment arm •To evaluate the effectiveness of Arm A compared to Arm B and Arm C compared to Arm A based on PROs of pain using the Worst Pain NRS •To assess the PK of imlunestrant (Arm A and Arm C) •To assess the PK of abemaciclib and its metabolites (Arm C);Primary end point(s): 1.Progression Free Survival (PFS) by investigator assessment • Investigator-assessed PFS (between Arm A and Arm B) in the ITT population • Investigator-assessed PFS (between Arm A and Arm B) in the ESR1-mutation detected population • Investigator-assessed PFS (between Arm C and Arm A) in the ITT population;Timepoint(s) of evaluation of this end point: 1. Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2. Overall Survival (OS) 3. Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) 4. Duration of Response (DoR) 5. 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 6. Patient Reported Outcomes (PRO): Time to Worsening of "Worst Pain" 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." 7. Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant 8.Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant and Abemaciclib ;Timepoint(s) of evaluation of this end point: 2. Randomization until death from any cause (estimated as up to 5 years) 3. Randomization until measured progressive disease (estimated as up to 1 year) 4. Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years) 5. Randomization until measured progressive disease (estimated as up to 1 year) 6. Screening through follow-up (estimated as up to 3 years) 7. Cycle 2 to Cycle 4 (cycle = 28 days) 8. Cycle 2 to Cycle 4 (cycle = 28 days) | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, China, Czechia, Czech Republic, France, Germany, Greece, India, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Russian Federation, Spain, Taiwan, Turkey, Ukraine, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed