Recruiting

Whole Breast Irradiation

Sponsor:

University of Virginia

Code:

NCT03567044

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Blood Draw

Study Details

Brief 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.

Conditions

Breast Cancer

Study ID

NCT03567044

Start date

Oct 1, 2018

Status verified date

Jun, 2018

Completion date

Mar, 2020

Anticipated

Primary completion date

Mar, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Blood Collection

Patients will be asked to have blood draws at specific time points during their whole breast irradiation.

Interventions

Blood Draw

Eligible subjects will have blood draws at the following times: baseline, 1 week, 4 weeks, 8 weeks, 12 weeks, 24 weeks.

Primary outcome measure

  • Lymphopenia [ Time Frame: Up to 6 months after treatment ]
  • Cytokines [ Time Frame: Up to 6 months after treatment ]

Central Contacts and Locations

Central contacts

Dena Snyder

434-243-6899ds6he@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Principal Investigator:

Shayna Showalter, MD

More Information

Sponsor

University of Virginia

Last update posted

Jun 25, 2018

Last verified

Jun, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2018-06-25.