OncoMatch/Clinical Trials/NCT03804944
Converting HR+ Breast Cancer Into an Individualized Vaccine
Is NCT03804944 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including CDX-301 and Pembrolizumab (200mg IV for 30 minutes for breast cancer.
Treatment: Pembrolizumab (200mg IV for 30 minutes · CDX-301 — Newly diagnosed post-menopausal women with clinical stage II-III, HR+HER2- breast cancer are eligible to a randomized trial, concurrently open at five US academic institutions. Patients receiving 4 months of standard neoadjuvant hormonal therapy with letrozole are randomly assigned to one of 4 arms of a trial testing focal hypo-fractionated RT alone or with immunotherapy combinations.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
Required: ESR1 positive
Required: PR (PGR) positive or negative
Disease stage
Required: Stage I (>1.5CM, IF N0), II, III (AJCC 8th edition)
Clinical stage I(>1.5cm, if N0) - III breast cancer, as per AJCC staging 8th edition.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic chemotherapy
Current use of systemic chemotherapy
Cannot have received: endocrine therapy
Current use of endoctine therap
Cannot have received: HER2-targeted therapy
Current use of HER2-neu targeted therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor 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: radiation therapy
Previous radiotherapy of the same breast.
Cannot have received: live vaccine
Has received a live vaccine within 30 days prior to the first dose of study drug.
Lab requirements
Blood counts
WBC ≥ 2000/uL Absolute neutrophil count (ANC) ≥1500/μL Platelets ≥100 000/μL Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La
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 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 (≤5 × ULN for participants with liver metastases)
Adequate bone marrow reserve and liver function: WBC ≥ 2000/uL Absolute neutrophil count (ANC) ≥1500/μL Platelets ≥100 000/μL Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La 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 participant with creatinine levels >1.5 × institutional ULN 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) International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cedars-Sinai Medical Center · Los Angeles, California
- Icahn School of Medicine at Mt Sinai · New York, New York
- New York Presbyterian Hospital - Queens · New York, New York
- Weill Cornell Medicine New York Presbyterian Hospital · New York, New York
- Brooklyn Methodist Hospital - NewYork Presbyterian · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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