OncoMatch/Clinical Trials/NCT04563507
Combined Immunotherapies in Metastatic ER+ Breast Cancer
Is NCT04563507 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04563507 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic chemotherapy, endocrine therapy, her2-targeted therapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression >10% is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 90 years or younger.
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 qualifyRelated pages