Breast CancerNCT03567044
Immune Effects in Patients Treated With Whole Breast Irradiation
A study testing Blood Draw in people with Breast Cancer, run by University of Virginia at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Blood Draw
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Dena Snyder
Shayna Showalter, MD
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Blood Draw
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawDiagnostic test
Eligible subjects will have blood draws at the following times: baseline, 1 week, 4 weeks, 8 weeks, 12 weeks, 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Blood Collection | Experimental | Patients will be asked to have blood draws at specific time points during their whole breast irradiation. Receives: Diagnostic Test: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphopenia
Incidence of lymphopenia
Measured: Up to 6 months after treatment
Cytokines
Change in patient's number of cytokines
Measured: Up to 6 months after treatment
Secondary outcomes (4)
Quality of Life
Changes in Patient-Reported Quality of Life using the EORTC QLQ-C30
Measured: Up to 24 months after treatment
Cosmetic Changes
Changes in physician reported cosmetic descriptions
Measured: Up to 24 months after treatment
Quality of Life
Changes in Patient-Reported Quality of Life using the EORTC QLQ-BR23.
Measured: Up to 24 months after treatment
Cosmetic Changes
Changes in patient reported cosmetic descriptions
Measured: Up to 24 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start1 Oct 2018 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shayna Showalter, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567044
- Sponsor's protocol ID
- 20476
- Status last verified
- Jun 2018
- First submitted
- 13 Mar 2018
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes and Immune Effects in Patients With Early Stage Breast Cancer Treated With Lumpectomy and Whole Breast Irradiation.
- ClinicalTrials.gov ID
- NCT03567044
- Acronym / sponsor ID
- 20476
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 25 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood Collection | Experimental | Diagnostic Test: Blood DrawPatients will be asked to have blood draws at specific time points during their whole breast irradiation. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawEligible subjects will have blood draws at the following times: baseline, 1 week, 4 weeks, 8 weeks, 12 weeks, 24 weeks. | Diagnostic test | Blood Collection |
Primary outcome
Lymphopenia
Time frame: Up to 6 months after treatment
Incidence of lymphopenia
Cytokines
Time frame: Up to 6 months after treatment
Change in patient's number of cytokines
4 secondary outcomes
Quality of Life
Time frame: Up to 24 months after treatment
Cosmetic Changes
Time frame: Up to 24 months after treatment
Quality of Life
Time frame: Up to 24 months after treatment
Cosmetic Changes
Time frame: Up to 24 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Draw in people with Breast Cancer, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dena Snyder (434-243-6899, ds6he@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphopenia (time frame: Up to 6 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.