Clinical Trial

Neoadjuvant DPX-Survivac Aromatase Inhibition, Radiotherapy or Cyclophosphamide in HR+HER2- Breast Cancer

Active, Not Recruiting Phase 1
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Summary
The study seeks to establish the safety of neoadjuvant aromatase inhibitor with: DPX-Survivac, DPX-Survivac plus radiation, or DPX-Survivac with cyclophosphamide in stage I to III HR+HER2- breast cancer. There will be sequential enrollment into 3 arms with an anticipated N=6 participants per arm for N=18 participants in total. All participants will receive letrozole 2.5 mg daily during the 6 weeks of neoadjuvant therapy. Neoadjuvant therapy occurs weeks 1-6, with standard of care surgery taking place week 7 to 9.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2021-05-19; most recent amendment 2026-04-07.
Status change: Recruiting → Active, Not Recruiting 2023-08-09
Status change: Not Yet Recruiting → Recruiting 2021-10-19
Trial Details
NCT Number NCT04895761
Lead Sponsor Providence Health & Services
Conditions Breast Cancer
Enrollment 6 participants
Start Date 2021-09-10
Primary Completion 2023-06-16 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-13