Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04895761
PHASE1

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

Sponsor: Providence Health & Services

View on ClinicalTrials.gov

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.

Official title: Phase Ib Study of Neoadjuvant DPX-Survivac, Aromatase Inhibition, and With/Without Radiotherapy or Cyclophosphamide in HR+HER2- Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2021-09-10

Completion Date

2026-09-01

Last Updated

2025-03-10

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

DPX-Survivac

DPX is a novel formulation that when combined with target antigens acts to activate T cells. It is a lipid-based formulation that creates a long lasting depot at the site of injection, forcing an "active uptake" by antigen presenting cells (APCs). APCs traffic to regional lymph nodes where naïve T cells are activated, inducing strong and sustained immune responses. All arms will receive DPX-Survivac on weeks 2 and 5.

DRUG

Letrozole 2.5mg

Aromatase inhibitor all arms will receive

DRUG

Cyclophosphamide 50mg

oral chemotherapy used in the neoadjuvant setting for Arm C only

RADIATION

XRT 10Gy x2

Directed radiation at week 4 for Arm B only

Locations (1)

Providence Portland Medical Center

Portland, Oregon, United States