Cynvenio Neoadjuvant Breast Cancer Registry Study

Study Summary:

Cynvenio and Targeted Medical Education Research (TME) are conducting a multi-center registry study which will include at least 10 specialized breast practices and over 150 patients to be monitored over three years with Cynvenio’s ClearID Breast Cancer blood test. Registry data will be leveraged to understand the value of ClearID as a treatment assessment and monitoring tool and to refine test algorithms.

Local/Regionally advanced (Stage 2 or 3) breast cancer patients undergoing neo-adjuvant chemotherapy (NAC) will be evaluated by the Cynvenio ClearID liquid biopsy test at multiple time points during their treatment and follow up.

Blood draws will be scheduled at the following intervals:

  1. Prior to beginning therapy
    Pre-neo-adjuvant chemotherapy ClearID analysis will be correlated to final pathology to look for biomarkers associated with response and non-response to neo-adjuvant chemotherapy.
     
  2. After 2-3 cycles of chemotherapy
    Testing after 2-3 cycles will be used to evaluate response to neo-adjuvant chemotherapy.
     
  3. Immediately prior to definitive surgery
    Testing immediately prior to definitive surgery will be used to determine if ClearID can be used to identify a group of patients with a 'blood complete response’ (bCR).  
     
  4. Prior to radiation therapy
    Similarly, ClearID testing prior to radiation therapy will be used to determine if definitive surgery removed all residual cancer, which could potentially determine the need for adjunctive radiation therapy.
     
  5. After radiation therapy
    ClearID testing after radiation therapy will be used to determine if radiation therapy destroyed all residual cancer, which could potentially determine the need for additional adjuvant systemic therapy (chemotherapy or hormonal).
     
  6. At 1 and 3 years after diagnosis.
    Lastly, the ClearID test  results will be evaluated for early detection of recurrence - correlating ClearID to imaging evidence of recurrence.
     

Additional Information 

+ Study Logistics

Targeted Medical Education Research (TME) is managing the multi-center registry study under their NEAT (Neoadjuvant Trial) Registry platform. There will be ~10 community based breast centers with a target accrual of 150 patients. Follow up will be 2 years.

+ Background

Neo-adjuvant systemic therapy is becoming more commonplace. The reasoning for this is: 1) to make definitive surgery easier and potentially preserve the breast, and 2) to determine if the systemic therapy is effective by leaving the cancer in situ and easily evaluable. Furthermore, the neo-adjuvant setting allows for more rapid identification of new biomarkers that correlate with response and non-response to prescribed therapy. Liquid biopsy has become reliable and is considerably easier/more cost effective than serial tissue biopsies.

By collecting tumor information via a liquid biopsy, patient data can be accrued at regular intervals via simple and minimally invasive blood draws often done in conjunction with monitoring and treatment standard of care blood draws. The registry data will help identify new biomarkers to assess patient response to treatment, measure resistance to chemotherapy, and identify new targets for alternative chemotherapy to enhance response rates.

+ Status

Currently enrolling patients through TME Research approved sites. For more information, please contact Cynvenio Client Services.

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