NCT03567044

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 25, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

June 25, 2018

Status Verified

June 1, 2018

Enrollment Period

1.4 years

First QC Date

March 13, 2018

Last Update Submit

June 21, 2018

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Quality of Life

    Up to 24 months after treatment

  • Cosmetic Changes

    Up to 24 months after treatment

  • Quality of Life

    Up to 24 months after treatment

  • Cosmetic Changes

    Up to 24 months after treatment

Study Arms (1)

Blood Collection

EXPERIMENTAL

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

Diagnostic Test: Blood Draw

Interventions

Blood DrawDIAGNOSTIC_TEST

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

Blood Collection

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Dena Snyder

CONTACT

434-243-6899ds6he@virginia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assistant Professor of Medicine, University of Virginia

Study Record Dates

First Submitted

March 13, 2018

First Posted

June 25, 2018

Study Start

October 1, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

June 25, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)