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Life sciences · Phase 1 Trial
ClinicalTrials.gov · November 2, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT03900884). This is a study registration, not published results. Lead sponsor: Peter MacCallum Cancer Centre, Australia. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 17 participants (ACTUAL). Conditions: Breast Neoplasm Female. Interventions: DRUG: Venetoclax; DRUG: Palbociclib; DRUG: Letrozole. Primary outcome measures: Determination of the Maximum Tolerated Dose (MTD), dose-limiting toxicities (DLTs) and recommended phase 2 dose of drug combination of palbociclib, letrozole and venetoclax. , 36 months. Brief summary: This study is investigating the combination of palbociclib, letrozole and venetoclax in ER and BCL-2 positive locally advanced or metastatic breast cancer. It is hypothesised that venetoclax may augment the actions of palbociclib and letrozole in these patient groups. The primary objective of the study is to determine the maximum tolerated dose of the combination treatment, which can be used in subsequent studies. The study will also investigate disease response and survival. Participants will receive palbociclib (daily, on days 1-21 of each 28 day cycle), letrozole (daily, on days 1-28 of each 28 day cycle) and venetoclax (daily, on days 1-21 of each 28 day cycle) until the last patient has completed 18 months treatment on the study.