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An observational study of circulating tumor DNA in triple negative breast cancers with residual disease after standard neoadjuvant treatment.

  • Study HIC#:2000033096
  • Last Updated:08/02/2023

Estimate the ctDNA positivity rate in triple negative breast cancer (TNBC) patients with residual disease after completion of neoadjuvant chemotherapy and surgery.

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    Eligibility Criteria

    Inclusion Criteria

    Participants must have histologically confirmed ER-, PR-, and HER2- (triple negative (TNBC) breast cancer). ER, PR, and HER2 negativity as per the 2018 joint ASCO/CAP guidelines. Participants must have residual invasive cancer  0.5cm in the breast or residual disease in an axillary lymph node after receiving neoadjuvant chemotherapy.

    Participants must have completed all intended neoadjuvant treatment for triple negative breast cancer as per standard of care and must have completed surgical resection.

    Participants must be within 6 weeks of definitive surgery to be eligible for registration.

    Participants must be ≥18 years of age.

    Participants must have an ECOG performance status < 4.

    Ability to understand and the willingness to sign a written informed consent document.

    Exclusion Criteria

    Participants with evidence of metastatic disease prior to registration.

    Participants who are unable to provide informed consent for the trial.

    Participants who are receiving any other investigational agents.

    Participants with inadequate tissue from diagnostic breast biopsy, prohibiting designing a personalized ctDNA assay

    For more information about this study, including how to volunteer, contact: