At a glance
ClinicalIndex Comparison Record- ✓Post-menopausal female ≥18 years old
- ✓ECOG performance status 0-1
- ✓ER+/HER2- breast cancer confirmed by biopsy
- ✓Clinical stage I-III breast cancer per AJCC 8th edition
- ✕Active connective tissue disorders requiring flare therapy (e.g., lupus, scleroderma)
- ✕Current systemic chemotherapy, endocrine therapy, or HER2-targeted therapy
- ✕Post-surgical excision of breast cancer already performed
- ✕Prior radiotherapy to the same breast
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Converting HR+ Breast Cancer Into an Individualized Vaccine
In Brief
A Phase 2 clinical trial evaluating Focal Radiation therapy, Pembrolizumab (200mg IV for 30 minutes, and 1 other intervention for Breast Cancer. Currently recruiting, targeting 100 participants across 8 sites.
Detailed 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.
Study Details
Timeline
Interventions
Focal hypo-fractionated radiation therapy 8 Gy x 3 fractions, starting day 8, every other day (M/W/F or W/F/M or F/M/W).
Pembrolizumab, on day 12 (last day of radiotherapy), infused over 200mg IV over 30 minutes and then repeated every 3 weeks until disease progression or unacceptable toxicity.
Ftl-3 ligand, self-administered by subcutaneous injections at week 1, daily, for 5 consecutive days.