Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients
Trial Parameters
Brief Summary
This is a single-arm, open-label phase IV study of patients with advanced HR+/HER2- breast cancer who are treated first line with ribociclib and standard of care endocrine treatment according to SmPC.
Eligibility Criteria
Inclusion Criteria: 1. Indication for treatment with ribociclib in combination with endocrine therapy in the locally advanced or 1st line metastatic therapy setting according to SmPC. (Previous treatment with cycline dependent kinase 4/6 (CDK4/6) inhibitors is allowed in the adjuvant setting) 2. Written informed consent prior to beginning of trial specific procedures 3. Subject must be female and aged ≥ 18 years on the day of signing informed consent 4. Locally advanced or metastatic breast cancer not amenable to curative treatment 5. Patient has HER2-negative breast cancer confirmed by local laboratory defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample tested by a local laboratory 6. Histologically confirmed estrogen receptor (ER) positive and/ or progesterone recep