OncoMatch/Clinical Trials/NCT06110793
A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer
Is NCT06110793 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Lenvatinib and Pembrolizuma for metastatic breast cancer.
Treatment: Lenvatinib · Pembrolizuma · Fulvestrant — The purpose of this study is to test whether the combination of lenvatinib, pembrolizumab, and fulvestrant is a safe and effective treatment that causes few or mild side effects in people with ER+/HER2- metastatic breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER >1%)
ER+ (ER >1%)
Required: HER2 (ERBB2) wild-type (HER2-)
HER2- breast cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy
Progressed on at least 1 prior endocrine therapy combined with CDK 4/6 inhibitor. Prior fulvestrant therapy is permitted.
Must have received: CDK4/6 inhibitor
Progressed on at least 1 prior endocrine therapy combined with CDK 4/6 inhibitor.
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
Cannot have received: VEGF inhibitor (lenvatinib)
Prior exposure to lenvatinib or any other VEGF-directed anti-angiogenic agent.
Cannot have received: systemic anti-cancer therapy
Exception: within 2 weeks prior to allocation
Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to allocation.
Cannot have received: radiation therapy
Exception: within 2 weeks of start of study intervention; 1-week washout permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
Has received prior radiotherapy within 2 weeks of start of study intervention.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1500/µL; Platelets ≥100,000/µL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L (criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks)
Kidney function
Creatinine OR measured/calculated creatinine clearance ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × ULN
Liver function
Total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ institutional normal range of 50% by MUGA or ECHO; QTcF ≤480 ms
Adequate organ function. Hematological: ANC ≥1500/µL, Platelets ≥100,000/µL, Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L. Renal: Creatinine OR measured/calculated creatinine clearance ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × ULN. Hepatic: Total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases). Cardiac: LVEF ≥ institutional normal range of 50% by MUGA or ECHO; QTcF ≤480 ms.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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