ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
ONO-4578-06: Phase I , Open-label, Non-blind, First-line Endocrine Therapy With ONO-4578 and Standard Treatment Letrozole and CDK4/6 Inhibitors (Palbociclib or Abemaciclib) in Patients With Metastatic or Recurrent Postmenopausal Hormone Receptor-positive HER2-negative Breast Cancer
Sponsor: Ono Pharmaceutical Co., Ltd.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Adverse events
Time frame: Through study completion, an average of 4 year
Serious adverse events
Time frame: Through study completion, an average of 4 year
Dose-limiting toxicity (Tolerability Confirmation part only)
Time frame: 28 days
Laboratory abnormality profile of Drugs as measured by incidence and severity of clinical laboratory abnormalities
Time frame: Through study completion, an average of 4 year
Secondary Endpoints
Overall response rate (ORR)
Disease control rate (DCR)
Clinical benefit rate (CBR)
Eligibility Criteria
Inclusion Criteria: 1. Patients with postmenopausal metastatic or recurrent breast cancer 2. Patients with ECOG Performance Status 0 to 1 3. ER-positive, PgR-positive and HER2-negative patients Exclusion Criteria: 1. Patients are unable to swallow oral medications 2. Patients with severe complication
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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