OncoMatch/Clinical Trials/NCT05452213
Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients
Is NCT05452213 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies Ribociclib for breast cancer.
Treatment: Ribociclib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (IHC 0 or 1+, or IHC 2+ with negative ISH) (IHC 0 or 1+, or IHC 2+ with negative ISH)
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
Required: ESR1 positive
Histologically confirmed estrogen receptor (ER) positive
Required: PR (PGR) positive
progesterone receptor (PgR) positive
Lab requirements
Blood counts
Adequate organ function amenable for treatment with ribociclib as assessed by local laboratory
Kidney function
Adequate organ function amenable for treatment with ribociclib as assessed by local laboratory
Liver function
Adequate organ function amenable for treatment with ribociclib as assessed by local laboratory
Cardiac function
QTcF < 450 ms; no long QT syndrome; no uncontrolled or significant cardiac disease (recent MI, CHF, unstable angina, bradyarrhythmia); no electrolyte abnormalities
corrected QT (QTcF) interval < 450 ms; Patients with long QT syndrome, uncontrolled or significant cardiac disease, or electrolyte abnormalities [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
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