OncoMatch/Clinical Trials/NCT05608252
VS-6766+Abema+Fulv in Met HR+/HER- BC
Is NCT05608252 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including VS-6766 and Abemaciclib for breast cancer.
Treatment: VS-6766 · Abemaciclib · Fulvestrant — This research is being done to evaluate the safety and effectiveness of a drug currently known as VS-6766 in combination with the drugs abemaciclib and fulvestrant in HR+/HER2-negative breast cancer. The names of the study drugs involved in this study are: * VS-6766 * Abemaciclib * Fulvestrant
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 estrogen receptor positive (positive per ASCO/CAP guidelines)
hormone receptor positive (HR+)...ER, PR and HER2 measurements should be performed according to institutional guidelines, in a CLIA-approved setting. Cut-off values for positive/negative staining should be in accordance with current ASCO/CAP guidelines.
Required: PR (PGR) progesterone receptor positive (positive per ASCO/CAP guidelines)
hormone receptor positive (HR+)...ER, PR and HER2 measurements should be performed according to institutional guidelines, in a CLIA-approved setting. Cut-off values for positive/negative staining should be in accordance with current ASCO/CAP guidelines.
Required: HER2 (ERBB2) negative (negative per ASCO/CAP guidelines)
HER2 negative...ER, PR and HER2 measurements should be performed according to institutional guidelines, in a CLIA-approved setting. Cut-off values for positive/negative staining should be in accordance with current ASCO/CAP guidelines.
Disease stage
Metastatic disease required
measurable or non-measurable disease according to RECIST v1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: CDK4/6 inhibitor — metastatic or adjuvant
progression on any CDK 4/6 inhibitor-containing regimen in the metastatic setting, and/or relapse/progression during or within 12 months of completion of any CDK4/6 inhibitor-containing regimen in the adjuvant setting
Must have received: fulvestrant (fulvestrant) — metastatic
progression on fulvestrant (as a single agent or as a component of any multi-drug regimen) in the metastatic setting
Cannot have received: MEK inhibitor
Prior treatment with any MEK inhibitor
Cannot have received: abemaciclib (abemaciclib)
Exception: discontinued prior abemaciclib for toxicity (phase I: any dose; phase II: if toxicity occurred at or above the RP2 dose level for abemaciclib that is incorporated into phase II of this trial)
Participants who have discontinued prior abemaciclib for toxicity
Cannot have received: fulvestrant (fulvestrant)
Exception: discontinued prior fulvestrant for toxicity
Participants who have discontinued prior fulvestrant for toxicity
Lab requirements
Blood counts
absolute neutrophil count ≥ 1.5 x 10^9/L; platelets ≥100,000/μl; hemoglobin ≥9 g/dL (If red blood cell transfusion has been administered, hemoglobin must remain stable and ≥9 g/dL without further transfusion for at least 1 week prior to first dose of study therapy)
Kidney function
creatinine clearance rate of ≥ 50 mL/min as calculated by the Cockcroft-Gault formula
Liver function
total bilirubin ≤1.5mg/dL (≤3.0mg/dL in patients with known Gilbert syndrome and direct bilirubin within normal limits); AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN
Cardiac function
left ventricular ejection fraction ≥ 50% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan; Baseline QTc interval < 480 ms (average of triplicate readings) using Fredericia's QT correction formula
Participants must have normal organ and marrow function as defined below: ... Adequate cardiac function with left ventricular ejection fraction ≥ 50% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan. Baseline QTc interval < 480 ms (average of triplicate readings) using Fredericia's QT correction formula.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Massachusetts General Hospital Cancer Center · Boston, Massachusetts
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana Farber Cancer Institite · Boston, Massachusetts
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