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Palbociclib in neoadjuvant HR+ breast cancer (PREDIX LumA)
NCT02592083Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Oct 2015
- Primary completion
- Feb 2019
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- palbociclib
- Conditions
- Hormone-Receptor-Positive Breast Cancer
01
Overview
Phase 2, randomised, open-label trial of palbociclib in Hormone-Receptor-Positive Breast Cancer. Started Oct 2015; status: active, not recruiting.
02
Design
- Study design
- RandomizedOpen-label
03
Registry description
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…
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