OncoMatch/Clinical Trials/NCT04563507
Combined Immunotherapies in Metastatic ER+ Breast Cancer
Is NCT04563507 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Letrozole 2.5Mg Tab and Palbociclib 125mg for breast cancer.
Treatment: Letrozole 2.5Mg Tab · Palbociclib 125mg — Women with Hormone Receptor (HR)+ Human Epidermal growth factor Receptor (HER)2- metastatic breast cancer are eligible to a randomized trial. Patients receiving standard first line therapy for metastatic HR+ Breast cancer(BC) (letrozole+palbociclib) are randomly assigned to also receive Stereotactic Body Radiation Therapy(SBRT) to each metastatic lesion.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression >10% (>10%)
ER expression is >10%
Required: HER2 (ERBB2) wild-type
HER2-
Disease stage
Metastatic disease required
Metastatic disease (≤ 5 sites of measurable disease by RECIST)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy (antiestrogen, aromatase inhibitor) — metastatic
Cannot have received: systemic chemotherapy
Cannot have received: endocrine therapy
Cannot have received: her2-targeted therapy
Lab requirements
Blood counts
WBC ≥ 2000/uL; ANC ≥1500/µL; Platelets ≥100 000/µL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L
Kidney function
Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for the participant with creatinine levels >1.5 × institutional 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
Hematological WBC ≥ 2000/uL; Absolute neutrophil count (ANC) ≥1500/µL; Platelets ≥100 000/µL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L; Renal Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for the participant with creatinine levels >1.5 × institutional 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Weill Cornell Medicine · New York, New York
- Brooklyn Methodist Hospital - NewYork Presbyterian · New York, New York
- New York Presbyterian Hospital - Queens · New York, New York
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