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NCT06207734
Discontinuation of CDK4/6 Inhibitors in Patients With Metastatic HR Positive, HER2 Negative Breast Cancer
This is a low-intervention, randomized, non-comparative, open-label, multicenter, prospective, phase II trial investigating discontinuation of CDK4/6 inhibitors in patients with metastatic HR positive, HER2 negative breast cancer with durable disease control.
Trial Details
NCT ID NCT06207734 Phase PHASE2
Sponsor Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Status RECRUITING
Cancer Type HER2 Positive Breast Cancer
Interventions Continuation of CDK4/6 inhibitor Palbociclib Discontinuation of CDK4/6 inhibitor Palbociclib Continuation of CDK4/6 inhibitor -Palbociclib Discontinuation of CDK4/6 inhibitor -Palbociclib Continuation of CDK4/6 inhibitor Abemaciclib Discontinuation of CDK4/6 inhibitor Abemaciclib Locations (sample) Berlin, Germany|52.52437,13.41053 Bremen, Germany|53.07582,8.80717 Dortmund, Germany|51.51494,7.466 Friedrichshafen, Germany|47.65689,9.47554 Gerlingen, Germany|48.79954,9.06316
Key Eligibility Criteria
Female patient has given written informed consent Patient is ≥ 18 years of age at time of signing the written informed consent Patient has been diagnosed with histologically confirmed metastatic adenocarcinoma of the breast Patient has documented histological or cytological confirmation of estrogen receptor positive (ER+) and HER2 negative (HER2-) disease For full eligibility, visit ClinicalTrials.gov .