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 (Jun 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
Treatments studied
Targeted therapy
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
Demographics
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.
Frequently asked questions
Is NCT05452213 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require ERBB2?
Yes, ERBB2 negative (IHC 0 or 1+, or IHC 2+ with negative ISH) is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 positive is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR positive is a required biomarker for enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify