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

Sponsor
Peter MacCallum Cancer Centre, Australia
Study ID
NCT03900884
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Breast Neoplasm Female

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    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.
  • Palbociclib — DRUG
    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.
  • Letrozole — DRUG
    Letrozole will be dosed daily at a fixed dose of 2.5 mg/day throughout the study.

Study Details

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.

Key Dates

Start date
Sep 25, 2019
Status verified
Nov 2024
Primary completion
Jun 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Letrozole + Palbociclib + Venetoclax
    The Letrozole dose is 2.5 mg (D1-28) for all dose levels. Starting dose Level 1: Palbociclib 100 mg (D1-21) and Venetoclax 100 mg (D1-21) daily.

Primary Outcome Measure

Determination of the Maximum Tolerated Dose (MTD), dose-limiting toxicities (DLTs) and recommended phase 2 dose of drug combination of palbociclib, letrozole and venetoclax. [ Time Frame: 36 months ]

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