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Checkpoint Inhibitor

Radiation + Immunotherapy for Breast Cancer (BreastVAX Trial)

Phase 1 & 2

Recruiting

Led By Julia C Tchou, MD

Research Sponsored by Abramson Cancer Center of the University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an ECOG Performance Status 0 - 1 at screening

Patients with newly diagnosed clinical T1-2 N0-1 M0 breast cancer not eligible for I-SPY2 or not undergoing neoadjuvant chemotherapy with specific features

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

BreastVAX Trial Summary

This trial is testing whether adding the immunotherapy drug pembrolizumab to a single fraction of radiation therapy is feasible in patients with early/operable breast cancer, and whether it leads to clinical responses.

Who is the study for?

This trial is for adults over 18 with early-stage breast cancer who can handle radiation therapy and have good overall health. They must not have had recent cancer treatments, no severe psychiatric or substance abuse issues, no active infections or certain viruses like HIV, Hepatitis B/C, and should not be pregnant.Check my eligibility

What is being tested?

The study tests if adding a single dose of radiation (hypofractionated radiotherapy) to pembrolizumab (an immune therapy drug) is feasible in treating early breast cancer. It also looks at how the tumor responds clinically and immunologically before and after treatment.See study design

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in organs, infusion reactions, fatigue, skin rash, digestive issues; while radiation might lead to localized skin irritation and fatigue.

BreastVAX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My breast cancer is in the early stages and I'm not receiving certain types of chemotherapy.

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I am 18 years old or older.

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I can undergo radiation therapy without severe side effects.

BreastVAX Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess clinical response of treatment

Feasibility of preoperative pembrolizumab administration combined with radiation boost in patients with operable breast cancer

Secondary outcome measures

Assess immune response on pre- and post-treatment blood and tissue samples

BreastVAX Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 4 (Historical Controls)Experimental Treatment1 Intervention

Arm 4 will not receive any study treatment. Subjects will undergo surgery on day 0 and follow a preoperative (Day 0) and postoperative blood (Day 30) and tissue (Day 0) sampling schedule.

Group II: Arm 2Active Control3 Interventions

Arm 2 will receive pembrolizumab on day -14 and radiotherapy on day -7. Subjects in all arms will undergo surgery on day 0 and follow the same postoperative blood sampling and safety schedule.

Group III: Arm 1Active Control3 Interventions

Arm 1 will receive radiotherapy on day -14 and pembrolizumab on day -7. Subjects in all arms will undergo surgery on day 0 and follow the same postoperative blood sampling and safety schedule.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor

359 Previous Clinical Trials

105,017 Total Patients Enrolled

41 Trials studying Breast Cancer

35,306 Patients Enrolled for Breast Cancer

Abramson Cancer Center at Penn MedicineLead Sponsor

387 Previous Clinical Trials

145,617 Total Patients Enrolled

44 Trials studying Breast Cancer

60,822 Patients Enrolled for Breast Cancer

Julia C Tchou, MDPrincipal InvestigatorUniversity of Pennsylvania

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04454528 — Phase 1 & 2

Breast Cancer Research Study Groups: Arm 4 (Historical Controls), Arm 2, Arm 1

Breast Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04454528 — Phase 1 & 2

Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04454528 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what medical contexts is Arm 2 typically employed?

"Arm 2 is generally prescribed for malignant neoplasms and can be used to treat certain cases of unresectable melanoma, microsatellite instability high, or those who have experienced disease progression following chemotherapy."

Answered by AI

What is the participant count for this experiment?

"Affirmative. Based on the information hosted by clinicaltrials.gov, this medical trial is actively searching for participants and was first posted in December 7th 2020. The study requires 27 patients to be recruited from one particular site with the most recent update being September 19th 2022."

Answered by AI

Has Arm 2 been tested in any prior clinical experiments?

"Presently, there are 961 clinical investigations into Arm 2 with 122 trials in the final phase. Most of these studies are centered around Houston, Texas; however, globally there exist 3527 active sites conducting research on this arm."

Answered by AI

Are there any remaining vacancies in this clinical experiment?

"Correct. Clinicaltrials.gov attests that this trial, which was initially made available on December 7th 2020 and subsequently updated on September 19th 2022 is actively recruiting patients. The study seeks to enrol 27 individuals at one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BreastVAX: Radiation Boost to Enhance Immune Checkpoint Blockade Therapy

Julia Tchou 2020. "BreastVAX: Radiation Boost to Enhance Immune Checkpoint Blockade Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04454528.