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 •Relapsed or progressed following endocrine therapy •Have received prior treatment with at least 2 chemotherapy regimens, of which 1 but no more than 2 have been administered in the metastatic setting •Have the presence of measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) •Have a performance status =1 on the ECOG scale •Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy •Have adequate organ function •Have negative serum pregnancy test within 7 days prior to randomization and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following last dose of study treatment •Are able to swallow oral medication 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 158 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 67
Exclusion criteria
Exclusion criteria: •Have clinical evidence or history of central nervous system metastasis •Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively •Have had major surgery within 14 days prior to randomization of study drug to allow for post-operative healing of the surgical wound and site(s) •Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest •Have active bacterial or fungal infection, or detectable viral infection •Have received treatment with a prior cyclin-dependent kinase (CDK4) and CDK 6 inhibitor •Have a preexisting chronic condition resulting in persistent diarrhea •Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy, in terms of Progression Free Survival (PFS), in patients with metastatic breast cancer for: •Abemaciclib 150 mg Q12H plus tamoxifen •Abemaciclib 150 mg Q12H •Abemaciclib 200 mg Q12H plus primary prophylactic loperamide ;Secondary Objective: •To evaluate the efficacy of abemaciclib monotherapy and in combination with tamoxifen, in terms of Objective Response Rate (ORR), Duration of Response (DoR), and Overall Survival (OS) •To assess the safety profile of abemaciclib monotherapy and in combination with tamoxifen •To characterize the PK of abemaciclib and its metabolites; in addition to tamoxifen and its active metabolite endoxifen •To compare self-reported evaluate impact on pain, pain interference, , disease symptom burdens, health status and overall quality of life ;Primary end point(s): Progression Free Survival: baseline to measured progressive disease or death from any cause ;Timepoint(s) of evaluation of this end point: Approximately 14 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Percentage of participants achieving complete response (CR) or partial response (PR), time frame from baseline to objective disease progression: Objective Response Rate •Duration of CR and PR: Duration of Response •Overall Survival •Pharmacokinetics: mean steady state exposure of abemaciclib and its metabolites •Pharmacokinetics: mean steady state exposure of tamoxifen and endoxifen •Change from baseline to end of study in pain and symptom burden assessment on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) •Change from baseline to end of study in pain and symptom burden assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) ;Timepoint(s) of evaluation of this end point: •Baseline to objective disease progression (approximately 14 months) •Duration of CR and PR (approximately 14 months) •Overall survival (approximately 36 months) •Pharmacokinetics of abemaciclib and its metabolites, postdose cycle 1, day 1 through postdose cycle 3, day 1 •Pharmacokinetics of tamoxifen and endoxifen, postdose cycle 1, day 1 through postdose cycle 3, day 1: •Change from baseline in pain and symptom burden assessment on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) (approximately 14 months) •Change from baseline in pain and symptom burden assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) (approximately 14 months) | — |
Countries
Argentina, Austria, Belgium, Brazil, Canada, Czech Republic, France, Germany, Italy, Mexico, Russian Federation, Spain, Taiwan, Turkey, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed