RECRUITING

BreastVAX: Radiation Boost to Enhance Immune Checkpoint Blockade Therapy

Conditions

Breast Cancer Immune checkpoint blockade

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-12-07

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04454528

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Triple negative breast cancer (TNBC) defined using the ASCO CAP guidelines with the following modification supported by a recent publication as ER ≤ 10%, PR ≤ 10%, HER2- determined by immunohistochemistry and/or fluorescence in situ hybridization analyses and with tumor size ≤ 2.5 cm; * HR+ HER2- breast cancer regardless of nodal status and age of diagnosis ≥ 50 * HR+ HER2- breast cancer and age of diagnosis \<50 with tumor size ≤ 2.5 cm and clinically node (+) * HR+ or HR- and HER2+ breast cancer with tumor size ≤ 2.5 cm * Ductal carcinoma in situ (DCIS) with microinvasion * Locally recurrent breast cancer of any receptor subtype with no prior radiation, not recommended to receive neoadjuvant chemotherapy and expecting surgical excision as part of treatment. 1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 of the study protocol OR 2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the treatment period and for at least 120 days for study treatments with risk of genotoxicity after the last dose of study treatment. * Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Medically accepted methods of birth control include a diaphragm, cervical cap, latex condoms, surgical sterility, intrauterine devices (IUDs), hormonal implants, injectable contraceptives, or birth control pills. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year. * Ability to tolerate radiation therapy (e.g., lie flat and hold position) * Demonstrate adequate hematologic, renal, hepatic, thyroid, and bone marrow function	* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies). * Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection.

Inclusion Criteria

Exclusion Criteria

* Triple negative breast cancer (TNBC) defined using the ASCO CAP guidelines with the following modification supported by a recent publication as ER ≤ 10%, PR ≤ 10%, HER2- determined by immunohistochemistry and/or fluorescence in situ hybridization analyses and with tumor size ≤ 2.5 cm;
* HR+ HER2- breast cancer regardless of nodal status and age of diagnosis ≥ 50
* HR+ HER2- breast cancer and age of diagnosis \<50 with tumor size ≤ 2.5 cm and clinically node (+)
* HR+ or HR- and HER2+ breast cancer with tumor size ≤ 2.5 cm
* Ductal carcinoma in situ (DCIS) with microinvasion
* Locally recurrent breast cancer of any receptor subtype with no prior radiation, not recommended to receive neoadjuvant chemotherapy and expecting surgical excision as part of treatment.
1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 of the study protocol OR
2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the treatment period and for at least 120 days for study treatments with risk of genotoxicity after the last dose of study treatment.
* Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Medically accepted methods of birth control include a diaphragm, cervical cap, latex condoms, surgical sterility, intrauterine devices (IUDs), hormonal implants, injectable contraceptives, or birth control pills. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.
* Ability to tolerate radiation therapy (e.g., lie flat and hold position)
* Demonstrate adequate hematologic, renal, hepatic, thyroid, and bone marrow function

* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
* Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection.

Contacts and Locations

Study Contact

Julia C Tchou, MD

CONTACT

215-615-7575

Julia.tchou@pennmedicine.upenn.edu

Michelle Gelman

CONTACT

215-882-2702

michelle_gelman@pennmedicine.upenn.edu

Principal Investigator

Julia C Tchou, MD

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

Julia C Tchou, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-07

Study Completion Date2025-08

Study Record Updates

Study Start Date2020-12-07

Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

Immune checkpoint blockade

Additional Relevant MeSH Terms

Breast Cancer