OncoMatch/Clinical Trials/NCT04315233
Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics
Is NCT04315233 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Ribociclib and Belinostat for metastatic breast cancer.
Treatment: Ribociclib · Belinostat — This is an open-label, multi-center, phase I study designed to assess the maximum tolerated dose of ribociclib and belinostat in combination. The trial will open with a dose escalation followed by an expansion cohort at the identified dose. Dose escalation will be open to the enrollment of patients diagnosed with triple-negative breast cancer or ovarian cancer. Dose expansion will only be open to patients diagnosed with triple-negative breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Ovarian Cancer
Biomarker criteria
Required: ESR1 wild-type (ER ≤ 1% by immunohistochemistry)
ER and PR ≤ 1% by immunohistochemistry
Required: PR (PGR) wild-type (PR ≤ 1% by immunohistochemistry)
ER and PR ≤ 1% by immunohistochemistry
Required: HER2 (ERBB2) wild-type (Her-2/neu negative (0 or 1+ by immunohistochemistry OR not-amplified by CAP/ASCO standards))
Her-2/neu negative (0 or 1+ by immunohistochemistry OR not-amplified by CAP/ASCO standards)
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: cdk4/6 inhibitor
Cannot have received: hdac inhibitor
Lab requirements
Blood counts
ANC > 1,500/mm3; Platelets > 100,000/mm3; Hemoglobin > 9g/dL
Kidney function
Serum creatinine levels ≤1.5 mg/dL; potassium, magnesium, and total calcium within normal limits or corrected before first dose
Liver function
Serum bilirubin levels ≤1.5 mg/dL (exceptions: active hemolysis or ineffective erythropoiesis; Gilbert's excluded); AST/ALT ≤ 2.5 X ULN (≤ 5 X ULN with liver metastasis); Alkaline phosphatase < 2.5 X ULN unless bone metastasis present in absence of liver metastasis
Cardiac function
Known left ventricular ejection fraction < 50% excluded; Baseline QTcF > 450 msec excluded; heart rate on qualifying ECG must be between 50 and 90 BPM; Uncontrolled arrhythmia, CHF, angina, recent MI, pericarditis, or cardiac surgery within 6 months excluded; Clinically significant arrhythmias, complete LBBB, high-grade AV block, congenital long QT syndrome excluded
Adequate organ function as defined as: ... See full criteria for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Huntsman Cancer Institute · Salt Lake City, Utah
- Inova Schar Cancer Institute · Fairfax, Virginia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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