Converting HR+ Breast Cancer Into an Individualized Vaccine
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 f
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * 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. |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Lead sponsor | Weill Medical College of Cornell University |
| Locations | Los Angeles, California, United States; New York, New York, United States; New York, New York, United States; New York, New York, United States; New York, New York, United States; Pittsburgh, Pennsylvania, United States (+2 more sites) |
| Start date | 2020-03-17 |
| NCT ID | NCT03804944 |
| Official listing | https://clinicaltrials.gov/study/NCT03804944 |