Immune Effects in Patients Treated With Whole Breast Irradiation

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03567044
• Other study ID #: 20476
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: March 2020

Study information

• Verified date: June 2018
• Source: University of Virginia
• Contact: Dena Snyder
• Phone: 434-243-6899
• Email: ds6he[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymphopenia	Incidence of lymphopenia	Up to 6 months after treatment
Primary	Cytokines	Change in patient's number of cytokines	Up to 6 months after treatment
Secondary	Quality of Life	Changes in Patient-Reported Quality of Life using the EORTC QLQ-C30	Up to 24 months after treatment
Secondary	Cosmetic Changes	Changes in physician reported cosmetic descriptions	Up to 24 months after treatment
Secondary	Quality of Life	Changes in Patient-Reported Quality of Life using the EORTC QLQ-BR23.	Up to 24 months after treatment
Secondary	Cosmetic Changes	Changes in patient reported cosmetic descriptions	Up to 24 months after treatment