Last updated on February 2018

Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive HER2-negative Early Breast Cancer

Brief description of study

The purpose of this study is to determine if ribociclib in combination with letrozole for 24 weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative Endocrine Prognostic Index (PEPI) score of 0 at surgery compared to patients treated with letrozole alone therefore allowing more patients excellent outcomes without chemotherapy.

Detailed Study Description

Subjects will be randomized (1:1:1) to either letrozole plus placebo vs. letrozole plus continuous dosing of ribociclib vs. letrozole plus intermittent dosing (3-weeks-on/1-week-off) of ribociclib.

The difference in clinical, pathologic and radiologic response as well as Pre-operative Endocrine Prognostic Index (PEPI) scores across the three treatments arms will be examined. Subjects will also be followed for 5 years post-treatment to determine if ribociclib in combination with letrozole for 24 weeks results in improved 5 year Relapse Free Survival (RFS) compared to letrozole alone.

Clinical Study Identifier: NCT02712723

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University of Kansas Cancer Center - Overland Park

Overland Park, KS United States
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University of Kansas Cancer Center - South

Kansas City, MO United States
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Recruitment Status: Open

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