RecruitingBreast Cancer
Converting HR+ Breast Cancer Into an Individualized Vaccine
Eligible age
18–90 yrs
Accepts
Women
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Weill Medical College of Cornell University
You may qualify if…
- ✓ Post-menopausal female ≥ 18 years of age (Post-menopausal status defined as either 1) at least 2 years without menstrual period or 2) or patients older than 50 with serological evidence of post-menopausal status or 3) hysterectomized patients of any age with FSH confirmation of post-menopausal status.
- ✓ Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- ✓ Biopsy proven diagnosis of ER+ PR+ or PR- HER2- breast cancer.
- ✓ Clinical stage I(\>1.5cm, if N0) - III breast cancer, as per AJCC staging 8th edition.
- ✓ Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document.
- ✓ 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
You may not qualify if…
- ✕ Active connective tissue disorders, such as lupus or scleroderma requiring flare therapy
- ✕ Current use of systemic chemotherapy, endoctine therap or HER2-neu targeted therapy
- ✕ Post surgical excision of breast cancer.
- ✕ Previous radiotherapy of the same breast.
- ✕ 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).
- ✕ Inability to obtain histologic proof of breast cancer
- ✕ Has received a live vaccine within 30 days prior to the first dose of study drug.
- ✕ Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
Where it's recruiting
Source: ClinicalTrials.gov · NCT03804944 · last updated 2026-01-28