A phase III, multicenter, 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).
Clinical Trial Information
Trial Contact: Jobson, Gillian S; Jarquin-Castillo, Katherine ; Durand, Jennifer
IRB No: WIRB 20182329
Protocol Abbrev: TRIO NATALEE
Principal Investigator: Ana Elisa Cuesta Fernandez, MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: TALEE TRIO 033
Treatment: Ribociclib with endocrine therapy as an adjuvant treatment
Therapies Involved: Oncology: Adjuvant
ClinicalTrials.gov ID: NCT03701334
The purpose is to evaluate the effect of the addition of ribociclib to standard adjuvant ET on iDFS in patients with HR-positive, HER2-negative Anatomic Stage Group II (that is either: N1; or N0 (T2-3, N0) with G2-3 and/or Ki67≥20%, excluding G1) and Anatomic Stage Group III EBC.
• Female or male ≥ 18 years-old.
• Female with known menopausal status or initiation of adjuvant ET (whichever occurs earlier)
• Histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization
• Positive for ER and/or PgR. HER2-negative
• Available archival tumor tissue
• Patient has received any CDK4/6 inhibitor
• Received prior treatment with tamoxifen, raloxifene or AIs for reduction in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within the last 2 years
• Prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin