Palbociclib, Letrozole & Venetoclax in ER and BCL-2 Positive Breast Cancer

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

September 25, 2019

Primary Completion Date

June 30, 2025

Study Completion Date

December 31, 2025

Conditions
Breast Neoplasm Female
Interventions
DRUG

Venetoclax

At commencement of study: Venetoclax will commence at 100 mg daily (oral) for days 1-21 of each 28 day cycle. This is a dose finding study so doses will be adjusted between 100 and 800 mg/day depending on dose escalation results and recommendation of the safety committee.

DRUG

Palbociclib

At commencement of study: Palbociclib will commence at 100 mg daily (oral) for days 1-21 of each 28 day cycle. This is a dose finding study so doses will be adjusted between 75 and 125 mg/day depending on dose escalation results and recommendation of the safety committee.

DRUG

Letrozole

Letrozole will be dosed daily at a fixed dose of 2.5 mg/day throughout the study.

Trial Locations (3)

3000

Peter MacCallum Cancer Centre, Melbourne

3052

Royal Melbourne Hospital, Melbourne

3084

Austin Health, Melbourne

All Listed Sponsors
lead

Peter MacCallum Cancer Centre, Australia

OTHER