Hormone receptor positive, Her2 positive advanced breast cancer
Conditions
Interventions
Product Name: abemaciclib
Product Code: LY2835219
Pharmaceutical Form: Capsule
INN or Proposed INN: abemaciclib
Other descriptive name: ABEMACICLIB
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have diagnosis of HR+, HER2+ metastatic breast cancer on the primary tumor or metastatic lesion 2. Have unresectable locally advanced recurrent breast cancer or metastatic breast cancer 3. Have adequate tumor tissue available and collected prior to randomization 4. Have previously received at least two HER2 directed therapies for advanced disease 5. Must have received trastuzumab emtansine (TDM1) in any disease setting 6. Must have received a taxane in any disease setting 7. Have discontinued all previous therapies for cancer (except trastuzumab) for at least 21 days for myelosuppressive agents or 14 days for non-myelosupprevice agents 8. Have postmenopausal status 9. Have performance status of 0 to 1 on the ECOG scale 10. Must have LVEF of 50% or higher at baseline 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 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: 1. Have visceral crisis 2. Known CNS metastases that are untreated, symptomatic or require steroids to control symptoms 3. Received prior treatment with any CDK4 or CDK6 inhibitor 4. Have had major surgery within 14 days prior to randomization 5. Received treatment with a drug that has not received regulatory approval for any indication within 14 to 21 days of randomization for non-myelosuppressive or non-myelosupprevice agent, respectively 6. Have serious preexisting medical conditions that would preclude participation in this study 7. Have a history within the last 6 months of symptomatic congestive heart failure, myocardial infarction or unstable angina 8. Have a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation or sudden cardiac arrest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the efficacy of abemaciclib plus trastuzumab plus fulvestrant and abemaciclib plus trastuzumab to standard-of-care single-agent chemotherapy of physician’s choice plus trastuzumab with respect to progression free survival (PFS). ;Secondary Objective: To review overall survival, objective response rate, duration of response, disease control rate, clinical benefit rate, safety and tolerability of abemaciclib, treatment impact on pain, disease symptoms and overall quality of life, pharmacokinetics of abemaciclib and relationship between abeamciclib, trastuzumab and fulvestrant exposure and clinical outcomes;Primary end point(s): Progression-free survival (PFS);Timepoint(s) of evaluation of this end point: One planned primary analysis for PFS performed after 165 events have been observed. Within 28 days of randomization, baseline tumor assessment will be performed for each patient. Repeat scans will be done every 6 weeks for 36 weeks from first dose of therapy, then every 9 weeks and within 14 days of clinical progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): OS rate, ORR, DoR, disease control., clinical benefit rate, safety and tolerability, impact on pain, disease symptom;Timepoint(s) of evaluation of this end point: Up to a total of 2 interim analysis and a final analysis for OS may be performed if PFS is significant for both abemaciclib arms. Health outcome scales are administered day 1 of each cycle. | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, France, Germany, Greece, Italy, Korea, Republic of, Mexico, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed