HR+, HER2-, Advanced or Metastatic Breast Cancer MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Have a diagnosis of HR+, HER2- breast cancer -Have either advanced disease not amenable to curative surgical treatment or metastatic disease. -Have radiologic evidence of disease progression or recurrence either On treatment with a CDK4 & 6 inhibitor (palbociclib, ribociclib, or abemaciclib) plus AI as initial therapy for advanced disease, or plus ET administered as adjuvant therapy for early-stage breast cancer -Have either measurable disease or non-measurable but evaluable disease. -Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale (Oken et al. 1982). -Must be deemed appropriate for treatment with ET. -Have discontinued previous treatments and recovered from the acute effects of therapy to at least Grade 1, except for residual alopecia and peripheral neuropathy. -Have adequate organ function. -Males and females may participate. Male participants must agree to use hormone suppression with a gonadotropin-releasing hormone agonist such as goserelin or leuprolide. Female participants must have postmenopausal status due to either surgical/natural menopause or ovarian suppression with a gonadotropin-releasing hormone agonist, such as goserelin or leuprolide. - Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of childbearing potential (WOCBP) must test negative for pregnancy prior to initiation of treatment. WOCBP must agree to use 2 forms of effective contraception where at least one form must be highly effective to prevent pregnancy while receiving study treatment, and for 2 years after the last dose of fulvestrant (or according to local approved fulvestrant label). 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 315 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: -Have visceral crisis, lymphangitic spread or leptomeningeal carcinomatosis -Have symptomatic or untreated central nervous system (CNS) metastasis. -Have a history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. -Have serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study - Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years -Have a known active systemic infection -Have received any intervening line of systemic therapy between disease recurrence/progression and study screening or more than 1 line of therapy for advanced or metastatic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of fulvestrant with or without abemaciclib;Secondary Objective: To further compare the efficacy of fulvestrant with or without abemaciclib To further characterize the safety profile of abemaciclib in combination with fulvestrant To compare PRO measures of fulvestrant with or without abemaciclib To characterize the pharmacokinetics (PK) of abemaciclib in combination with fulvestrant;Primary end point(s): To compare PFS of fulvestrant with or without abemaciclib as determined by investigator assessment using RECIST 1.1;Timepoint(s) of evaluation of this end point: first occurrence of documented disease progression per RECIST 1.1, or death from any cause in the absence of documented progressive disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints: overall survival (OS), progression-free survival (PFS) by BICR, objective response rate (ORR), clinical benefit rate (CBR), disease control rate (DCR), duration of response (DoR) Safety endpoint: including but not limited to TEAEs, SAEs, deaths and clinical laboratory abnormalities Time to worsening in worst pain via the mBPISF worst pain item Time to deterioration in physical function via the EORTC IL-19 Concentrations of abemaciclib ;Timepoint(s) of evaluation of this end point: first occurrence of documented disease progression per RECIST 1.1, or death from any cause in the absence of documented progressive disease. At the end of the trial | — |
Countries
Argentina, Australia, Belgium, China, Czechia, Czech Republic, Denmark, France, Greece, Hungary, Israel, Italy, Korea, Republic of, Mexico, Poland, Russian Federation, Spain, Sweden, Taiwan, Turkey, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed