Femara (Letrozole) Plus Ribociclib (LEE011) or Placebo as Neo-adjuvant Endocrine Therapy for Women with ER-positive, HER2-negative Early Breast Cancer
Sponsor: |
Novartis |
Enrolling: |
Female Patients Only |
IRB Number: |
AAAR0658 |
U.S. Govt. ID: |
NCT02712723 |
Contact: |
Meghna Trivedi MD: 212-305-1945 / mst2134@cumc.columbia.edu |
The goal of this study is to determine if ribociclib in combination with letrozole as neoadjuvant endocrine therapy increases the proportion of women with PEPI score of 0 at surgery, compared to patients treated with letrozole alone therefore allowing more patients excellent outcomes without chemotherapy. The PEPI score measures the risk of breast cancer returning in women who received endocrine (hormone) therapy before for surgery. This technique uses tumor size, cancers proximity to lymph nodes, hormone receptor status of the cancer, and Ki67 (a cellular protein) blood levels to calculate this risk.
This study is closed
Investigator
Meghna Trivedi, MD
Are you a woman who is 18 years of age or older? |
Yes |
No |
Do you have invasive breast cancer? |
Yes |
No |
Are you postmenopausal (had your ovaries removed, no period for 1year, or your hormone levels are in postmenopausal range)? |
Yes |
No |