Breast Cancer Clinical Trial
Circulating Tumor DNA and Immunophenotyping as Potential Biomarkers With Regional Nodal Irradiation for Breast Cancer
The purpose of this research is to study the trends of circulating tumor DNA (ctDNA) and changes in immune cells (T cells) during and following radiation treatment for breast cancer. You have been asked to take part in this research because you are being treated with radiation therapy for breast cancer and will have radiation treatment to your lymph nodes.
Patients will be asked to participate in 3-4 blood draws, 60 mL each, during radiation treatment and allow study staff to review medical records.
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
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
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