Breast Cancer TRIO033

A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant Trial With Ribociclib [LEE011]: NATALEE)

Eligibility Criteria

• Patient is female with known menopausal status at the time of PICF signature or initiation of adjuvant ET (whichever occurs earlier), or male.
• Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization.
• Patient has breast cancer that is positive for ER and/or PgR
• Patient has HER2-negative breast cancer
• Patient has available archival tumor tissue from the surgical specimen
• Patient after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and who belongs to one of the following categories (anatomic stage group II or III)

This study is for patients age 18 and older.

Available at: Hospital of Central Connecticut