Breast Cancer HER2
Conditions
Interventions
During Treatment phase ribociclib or ribociclib matching placebo will be given
orally once a day on days 1-21 of each 28 day cycle. Days 22-28 of each cycle
will be a *rest* period from ribociclib o
Adjuvant Ribociclib with Endocrine Therapy in Hormone Receptor+/HER2-
High Risk Early Breast Cancer (EarLEE-1)
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Histologically confirmed unilateral primary invasive adenocarcinoma of the breast * Estrogen receptor-positive and/or progesterone receptor-positive, HER2-negative breast cancer * Patient is after surgical resection of the tumor where tumor was removed completely with the final surgical specimen microscopic margins free from tumor and with available archival tumor tissue from the surgical specimen * Patient who have AJCC 8th edition Prognostic Stage Group III tumor; or patient who received neoadjuvant chemotherapy and have 1 or more ipsilateral axillary lymph nodes with residual tumor metastases greater than 2.0 mm in lymph node(-s) and residual tumor greater than 10.0 mm in breast tissue • Patient has completed multi-agent adjuvant or neoadjuvant chemotherapy of >= 4 cycles or >= 12 weeks which included taxanes prior to screening * Patient has completed adjuvant radiotherapy (if indicated) prior to screening * Patient may already have initiated adjuvant endocrine therapy (ET) at the time of randomization, but randomization must take place within 52 weeks of date of initial histological diagnosis of breast cancer and within 12 weeks of initiating ET * ECOG Performance Status 0 or 1 * Adequate bone marrow and organ function * Sodium, potassium, phosphorus, magnesium and total calcium laboratory values within normal limits * QTcF interval
Exclusion criteria
Exclusion criteria: * Prior treatment with CDK4/6 inhibitor * Prior treatment with tamoxifen, raloxifen or aromatase inhibitors for reduction in risk (chemoprevention) of breast cancer and/or treatment for osteoporosis within 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 * Distant metastases of breast cancer beyond regional lymph nodes * Patient has not recovered from clinical and laboratory acute toxicities of chemotherapy, radiotherapy and surgery * Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, or clinically significant cardiac arrhythmias * Uncontrolled hypertension with systolic blood pressure >160 mmHg * Patient is currently receiving any of the prohibited substances that cannot be discontinued 7 days prior to Cycle 1 Day 1: concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5; medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5; systemic corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Invasive disease-free survival (iDFS) using STEEP criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| - Recurrence-free survival (RFS) using STEEP criteria - Distant disease-free survival (DDFS) using STEEP criteria - Overall survival (OS) - Quality of Life (QOL) | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea (the Republic of), Lebanon, Mexico, Netherlands, Poland, Romania, Russian Federation, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan (Province of China), Thailand, Turkey, United Arab Emirates, United Kingdom, United States of America
Outcome results
None listed