Last updated on June 2018

Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer

Brief description of study

This is a randomized trial for patients with metastatic hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have progressed on an aromatase inhibitor plus a CDK4/6 inhibitor (either palbociclib or ribociclib) to either fulvestrant alone or fulvestrant with ribociclib (LEE-011). The purpose of the trial is to determine whether there is continued benefit for patients to remain on a CDK4/6 inhibitor at the time of switching anti-estrogen therapy. As ribociclib and palbociclib have a similar toxicity and drug profile and mechanism of action, we feel that it is appropriate for patients to receive either drug with an aromatase inhibitor prior to randomization.

Detailed Study Description

Despite advances in early detection and therapeutic options, unresectable or metastatic breast cancer remains incurable and is one of the leading causes of cancer-related mortality. Breast cancer is a molecularly heterogeneous disease. This study will be evaluating estrogen receptor (ER) expression positivity and/or progesterone receptor (PgR) positivity of breast cancer with the absence of over-expression or amplification of HER2.

Inhibitors of the cyclin dependent kinases 4 and 6 (CDK4/6) have been developed and demonstrated impressive activity in patients with ER-positive HER2-negative breast cancer with marked improvements in progression free survival. This question is asking whether CDK 4/6 inhibition should be continued with hormone therapy in patients who will be switching their hormone therapy in the metastatic breast cancer setting.

Clinical Study Identifier: NCT02632045

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Chris Vaklavas, MD

University of Alabama at Birmingham (UAB)
Birmingham, AL United States
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William Gradishar, MD

Northwestern Medical Hospital
Chicago, IL United States
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Mark Hoffman, MD

Northwell Health/Monter Cancer Center
Lake Success, NY United States
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Francisco Esteva, MD, PhD

NYU Langone Medical Center
New York, NY United States
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Amy Tiersten, MD

Mount Sinai Medical Center
New York, NY United States
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Kevin Kalinsky, MD, MS

Columbia University Medical Center
New York, NY United States
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Eleni Andreopoulou, MD

Weill Cornell Medical Center
New York, NY United States
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Lea Baer, MD

Stony Brook Cancer Center
Stony Brook, NY United States
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Ingrid A Mayer, MD

Vanderbilt-Ingham Cancer Center
Nashville, TN United States
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Ruth O'Regan, MD

University of Wisconsin School of Medicine
Madison, WI United States
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Sun Young Oh, MD

Albert Einstein University / Montefiore Medical Center
Bronx, NY United States
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