Immune Effects in Patients Treated With Whole Breast Irradiation

Outcomes and Immune Effects in Patients With Early Stage Breast Cancer Treated With Lumpectomy and Whole Breast Irradiation.

The purpose of this study is to obtain data to determine whether whole breast irradiation (WBI) differentially influences the frequency of components of innate and adaptive immunity and their relative functional activity, to assess the patient's quality of life (QOL) and to evaluate the cosmetic assessment of the breast on follow-up after WBI treatment.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: Blood Draw

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia
      • Principal Investigator: Shayna Showalter, MD
      • Contact: Dena Snyder

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Willingness and ability to provide written informed consent and to comply with the study protocol as judges by the investigator.
• Patient has new diagnosis of breast cancer and has elected BCS and WBI. These patients must be consented prior to the start of WBI.
• For patients with invasive breast cancer sentinel node biopsy (SLNB) must be performed and confirm pathologic negative disease.
• Tumor size must be less than or equal to 3 cm.
• Patient is 45 years of age or older.
• Women of childbearing potential must agree to use adequate contraception prior to study entry and through the WBI treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Exclusion Criteria:

• Male patients
• Patients who are pregnant or nursing.
• Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the duration of the study or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
• Breast cancer that involves the skin or the chest wall.
• History of ipsilateral breast cancer treated with radiation therapy.
• Multicentric breast cancer in the ipsilateral breast as diagnosed by clinical exam, mammogram, ultrasound, or MRI
• Patients known to have a BRCA gene mutation. Genetic testing is not required.
• Patient with clinically positive nodal disease.
• Patient with proven nodal disease by either FNA, core biopsy or sentinel node biopsy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood Collection; Patients will be asked to have blood draws at specific time points during their whole breast irradiation.	Diagnostic test: Blood Draw; Eligible subjects will have blood draws at the following times: baseline, 1 week, 4 weeks, 8 weeks, 12 weeks, 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymphopenia	Incidence of lymphopenia	Up to 6 months after treatment
Cytokines	Change in patient's number of cytokines	Up to 6 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Changes in Patient-Reported Quality of Life using the EORTC QLQ-C30	Up to 24 months after treatment
Cosmetic Changes	Changes in physician reported cosmetic descriptions	Up to 24 months after treatment
Quality of Life	Changes in Patient-Reported Quality of Life using the EORTC QLQ-BR23.	Up to 24 months after treatment
Cosmetic Changes	Changes in patient reported cosmetic descriptions	Up to 24 months after treatment

Collaborators and Investigators

• Sponsor: University of Virginia

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: June 21, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2018
• Last Update Submitted That Met QC Criteria: June 21, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 20476 (Other Identifier: City of Hope Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No