The study is designed to compare the clinical benefit following treatment with letrozole in combination with Palbociclib versus letrozole in combination with placebo in Asian postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.
Conditions: Breast Neoplasms
Eligibility Criteria
Inclusion Criteria
- Adult Asian women with locoregionally recurrent or metastatic disease not amenable to curative therapy
- Confirmed diagnosis of ER positive breast cancer
- No prior systemic anti-cancer therapy for advanced ER+ disease
- Postmenopausal women
- Measurable disease as per Response Evaluation Criterion in Solid Tumors \[RECIST\] or bone-only disease
- Eastern Cooperative Oncology Group \[ECOG\] 0-1
- Adequate organ and marrow function
- Patient must agree to provide tumor tissue
Exclusion Criteria
- Confirmed diagnosis of HER2 positive disease
- Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
- Known uncontrolled or symptomatic CNS metastases
- Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment
- Prior treatment with any CDK 4/6 inhibitor
Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.