Spots Global Cancer Trial Database for Palbociclib, Letrozole & Venetoclax in ER and BCL-2 Positive Breast Cancer
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Trial Identification
Brief Title: Palbociclib, Letrozole & Venetoclax in ER and BCL-2 Positive Breast Cancer
Official Title: A Phase 1b Study of Palbociclib, Letrozole and Venetoclax in ER and BCL-2 Positive Locally Advanced or Metastatic Breast Cancer
Study ID: NCT03900884
Conditions
Study Description
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Royal Melbourne Hospital, Melbourne, Victoria, Australia
Austin Health, Melbourne, Victoria, Australia
Contact Details
Name: Geoffrey Lindeman, MBBS FRACP PhD
Affiliation: Peter MacCallum Cancer Centre, Australia
Role: PRINCIPAL_INVESTIGATOR
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