Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors
Status:
Active, not recruiting
Trial end date:
2029-02-01
Target enrollment:
Participant gender:
Summary
The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of the cdk 4/6
inhibitor palbociclib when added to standard endocrine treatment. Initially, patients receive
endocrine treatment for 4 weeks. In case of decrease of proliferation (Ki67) patients are
then randomized between either continuous endocrine therapy (arm A) or the same treatment
with addition of palbociclib (arm B). Patients with no change of proliferation are allocated
to endocrine treatment + palbociclib without randomization (arm C). During the 12-weekly
treatment period, clinical and radiological evaluations are performed repeatedly. Switch
between the treatment arms A and B is allowed in case of lack of response or due to toxicity.
A translational subprotocol is a mandatory part of the study protocol, except for use of
PET-CT evaluations.