NCT04454528

BreastVAX: Radiation Boost to Enhance Immune Checkpoint Blockade Therapy

Preoperative Use of Radiation Boost to Enhance Effectiveness of Immune Checkpoint Blockade Therapy in Operable Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to determine the feasibility of combining pembrolizumab with a single fraction radiation boost in patients with early/ operable breast cancer. The secondary objectives are to assess clinical response on pre- and post-treatment clinical, imaging, and histology exams, and to assess immune response on pre and post treatment blood and tissue samples by tracking change in Ki67 + CD8 T cells in peripheral blood and in extent of tumor infiltrating lymphocytes. A clinically significant partial response is defined as \>30% tumor shrinkage post-clinical trial intervention.

Detailed description

The study has four arms. Arms 1 and 2 differ by the order of radiation boost and pembrolizumab administration. A minimum of 6 patients will be enrolled in the safety run-in portion of the study. The Phase 2 portion of the study will include Arm 3 (pembrolizumab only arm). An estimated 27 participants will be enrolled or until futility of Arm 3 is reached. Continuation of enrollment in Arms 1 or 2 will be contingent to funding availability. Arm 4 represents our control arm in which patients will follow usual care but will be consented for blood/tissue collection using a separate protocol (Penn IRB 801539).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Hypofractionated radiotherapy	Radiation boost (RT) 7 Gy x 1 fraction on Day -14/Day -7 (arm 1) or Day -7/Day -14
DRUG	Pembrolizumab infusion	Pembrolizumab infusion flat dosing 200 mg delivered over 30 minutes.
PROCEDURE	Blood and tissue sampling	Blood will be collected for laboratory studies and complete correlative studies to examine how the subject's immune system is responding to treatment. On day 0, samples of tumor and any lymph nodes removed from armpit will be analyzed by the UPenn Department of Pathology according to standard practice.

Timeline

• Start date: 2020-12-07
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2020-07-01
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study