WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This is an open-label, single-arm, phase I trial. It is designed with a conservative dose
escalation plan to ensure patient's safety and with a strong translational component to
inform if target inhibition is achieved. With concerns regarding safety, based on extensive
available pharmacokinetic data and clinical efficacy experience, bosutinib will be given
5-days in a row followed by 2 days rest in a weekly basis, instead of daily.
The protocol will enroll patients per 3+3 escalation design. The Dose Limiting Toxicity (DLT)
observation period is 28 days. At the end of DLT observation period of each cohort of 3
patients, decision will be made regarding further escalation or de-escalation according to
this plan. Once the MTD of the combination is reached, the safety data will be analyzed.
There will be no dose reductions during DLT observation period. Dose reduction within
patients (individually) is allowed after the 4-week DLT observation period. Treatment in this
phase I trial will be administered until there is disease progression or unacceptable
toxicity.