Circulating Tumor DNA and Immunophenotyping as Potential Biomarkers With Regional Nodal Irradiation for Breast Cancer
Active, not recruiting
- Conditions
- Breast Cancer
- Registration Number
- NCT04308720
- Lead Sponsor
- Mayo Clinic
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 217
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the ctDNA detection 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
Mayo Clinic in Rochester🇺🇸Rochester, Minnesota, United States