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This study evaluates the combination of H3B-6545 and Palbociclib in women with advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer. To take part, patients should have received prior therapy in the advanced or metastatic setting and be in generally good health. The study is being conducted in Phase 1 and is active but not currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. ER+ HER2- locally advanced, recurrent, or metastatic breast cancer, as per local laboratory 2. Prior therapy in the advanced/metastatic setting 3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Has adequate bone marrow and organ function Exclusion Criteria: 1. Uncontrolled significant active infections 2. Major surgery or other locoregional treatment within 4 weeks before the 1st dose of study drug 3. Inability to take oral medication or presence of malabsorption 4. Active cardiac disease or a history of cardiac dysfunction 5. Evidence of ongoing Alcohol or Drug Abuse