Breast Cancer Clinical Trial

Circulating Tumor DNA and Immunophenotyping as Potential Biomarkers in Patients Undergoing Regional Nodal Irradiation for Breast Cancer

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

18 years of age or older
Histological confirmation of primary or recurrent invasive breast cancer with plans for adjuvant radiation therapy at the Mayo Clinic.
Must have had lumpectomy or mastectomy
Must have indication for regional nodal irradiation
Willing to sign consent and express understanding of this protocol and its requirements, risks, and discomforts
Must have completed final breast surgery including re-excision of margins for invasive cancer and DCIS or Chemotherapy within 90 days prior to registration but no sooner that 21 days prior to RT start
Oligometastatic breast cancer (≤ 3 sites of metastases) is permitted provided that the disease is managed with curative intent
Bilateral breast cancer is permitted
Positive or close margins is allowed

Exclusion Criteria:

History of prior malignancy < 2 years of enrollment, except non-melanotic skin cancer or carcinoma-in-situ of the cervix
Pregnancy or lactation
Inability to understand consent or stay compliant with the protocol

Study is for people with:

Breast Cancer

Estimated Enrollment:

400

Study ID:

NCT04308720

Recruitment Status:

Recruiting

Sponsor:

Mayo Clinic

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There is 1 Location for this study

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Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States More Info
Jessica Schneider
Contact
507-293-1230
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

400

Study ID:

NCT04308720

Recruitment Status:

Recruiting

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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