Breast CancerNCT04308720
Circulating Tumor DNA and Immunophenotyping as Potential Biomarkers With Regional Nodal Irradiation for Breast Cancer
An observational study of Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
This study will assess how radiation affects the patterns of circulating tumor deoxyribonucleic acid (ctDNA) and immune cells (T cells) during radiation treatment in patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 20 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women ages 18 and older with high-risk breast cancer with plan for adjuvant radiation therapy including the regional lymph nodes at Mayo Clinic.
Who may be able to join
- 18 years of age or older
- Histologically confirmed primary or recurrent non-metastatic invasive breast cancer with plans for adjuvant post-lumpectomy or post-mastectomy radiation therapy at the Mayo Clinic and indications for regional nodal irradiation.
- Or patients undergoing curative intent irradiation for oligometastatic breast cancer (=< 3 sites of metastases) is permitted
- Willingness to provide informed consent and expresses understanding of this protocol and its requirements, risks, and discomforts
- Patients with non-metastatic breast cancer must have completed their final breast surgery including re-excision of margins for invasive cancer and ductal carcinoma in situ (DCIS) or chemotherapy within 90 days prior to registration but no sooner than 21 days prior to the initiation of radiation therapy (RT).
- Bilateral breast cancer is permitted
- Positive or close margins is allowed
Who cannot join
- Other active malignancy =< 2 years prior to registration (exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix)
- Pregnancy or lactation
- Inability on the part of the patient to understand the informed consent to be compliant with the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Circulating Tumor DNA (ctDNA) and Immunophenotyping as Potential Biomarkers in Patients Undergoing Regional Nodal Irradiation for Breast Cancer
This study will assess how radiation affects the patterns of circulating tumor deoxyribonucleic acid (ctDNA) and immune cells (T cells) during radiation treatment in patients with breast cancer. By better understanding how radiation therapy affects these markers (characteristic that is measured to see how well the body responds to a treatment for a disease) in the blood, researchers may better customize treatments for patients with breast cancer in the future.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the ctDNA detection
Assessed by the number of patients who have undetectable ctDNA post-treatment, among patients that were detectable pre-treatment.
Measured: Baseline to 3 months post-treatment (treatment typically lasts 3-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Oct 2019
- Primary completion20 Oct 2028 (estimated)
- Study completion20 Oct 2028 (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 Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert W. Mutter, M.D., Principal investigator, Mayo Clinic Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308720
- Sponsor's protocol ID
- 19-003532
- Other IDs
- ROR1931
- Status last verified
- Jun 2026
- First submitted
- 7 Feb 2020
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA (ctDNA) and Immunophenotyping as Potential Biomarkers in Patients Undergoing Regional Nodal Irradiation for Breast Cancer
- ClinicalTrials.gov ID
- NCT04308720
- Acronym / sponsor ID
- 19-003532
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 20 Oct 2028 (estimated)
- Study completion
- 20 Oct 2028 (estimated)
- First posted
- 16 Mar 2020 (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.
This study will assess how radiation affects the patterns of circulating tumor deoxyribonucleic acid (ctDNA) and immune cells (T cells) during radiation treatment in patients with breast cancer. By better understanding how radiation therapy affects these markers (characteristic that is measured to see how well the body responds to a treatment for a disease) in the blood, researchers may better customize treatments for patients with breast cancer in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women ages 18 and older with high-risk breast cancer with plan for adjuvant radiation therapy including the regional lymph nodes at Mayo Clinic.
Key inclusion criteria (7 listed)
- 18 years of age or older
- Histologically confirmed primary or recurrent non-metastatic invasive breast cancer with plans for adjuvant post-lumpectomy or post-mastectomy radiation therapy at the Mayo Clinic and indications for regional nodal irradiation.
- Or patients undergoing curative intent irradiation for oligometastatic breast cancer (=< 3 sites of metastases) is permitted
- Willingness to provide informed consent and expresses understanding of this protocol and its requirements, risks, and discomforts
- Patients with non-metastatic breast cancer must have completed their final breast surgery including re-excision of margins for invasive cancer and ductal carcinoma in situ (DCIS) or chemotherapy within 90 days prior to registration but no sooner than 21 days prior to the initiation of radiation therapy (RT).
Key exclusion criteria (3 listed)
- Other active malignancy =< 2 years prior to registration (exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix)
- Pregnancy or lactation
- Inability on the part of the patient to understand the informed consent to be compliant with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in the ctDNA detection
Time frame: Baseline to 3 months post-treatment (treatment typically lasts 3-6 weeks)
Assessed by the number of patients who have undetectable ctDNA post-treatment, among patients that were detectable pre-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Robert W. Mutter, M.D. principal investigator
Mayo Clinic Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Mayo Clinic 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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the ctDNA detection (time frame: Baseline to 3 months post-treatment (treatment typically lasts 3-6 weeks)). 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 18 Jun 2026.