Study Title:

A Pilot Surveillance Study to Monitor Natural Killer Cells and Circulating Tumor Cells in Women with Previously Treated Non-metastatic Triple Negative Breast Cancer and Women with Previously Treated Non-metastatic Breast Cancer With a confirmed BRCA Mutation.

Study Summary:

Cynvenio is conducting a clinical research study to monitor women with triple negative breast cancer and/or breast cancer with a confirmed BRCA mutation who have completed therapy and show no signs of metastases.

Background:

Of the estimated 1 million cases of breast cancer diagnosed annually worldwide, it is estimated that over 170,000 will have the triple-negative breast cancer (TNBC), a subtype that is negative for estrogen receptor/progesterone receptor/Her-2 receptor expression.

Few women with triple negative breast cancer experience a local recurrence before a distant recurrence, with higher incidences of recurrence in visceral organs and soft tissue and lower rates of bone disease.

BRCA1 and BRCA2 are human genes that produce tumor suppressor proteins. Together, BRCA1 and BRCA2 mutations account for about 20 to 25 percent of hereditary breast cancers and about 5 to 10 percent of all breast cancers (Thompson 2002). Women with a BRCA1 mutation were 1.5 times more likely to see a breast cancer recurrence, and 1.4 times more likely to die from breast cancer at 15 years’ follow-up compared with non-carriers¹.

There has been extensive data showing decreased NK cell activity in cancer patients compared to the general population.  A study by Santos described the relationship between low NK cell activity and increased presence of circulating tumor cells (CTC) in patients with metastatic breast, colorectal, and prostate cancer.

Status:

Enrollment in this two year study is now closed.

Eligibility Criteria:

  • Women with Previously Treated Non-metastatic Triple Negative Breast Cancer or Women with Previously Treated Non-metastatic Breast Cancer With a confirmed BRCA Mutation who have completed therapy within three years of enrollment in this study.
  • Over 18 years of age.

Exclusion Criteria:

  • Known HIV, Hepatitis B or Hepatitis C infection
  • Any reason a blood draw could not be performed

Study Activities:

Every Month  

Study participants will have the option to monitor NK cell activity with the NK Score™ blood test.

Every 3 Months 

Participants will have their blood checked for evidence of circulating tumor cells (CTCs) using the ClearID™ blood test. If CTCs are identified, further genomic profiling of the CTC and cell free DNA will be performed to help guide additional treatment. The NK Score™ blood test will be performed every three months if not opted for monthly.

v¹ Schmidt MK, et al Breast cancer survival of BRCA1/2 carriers compared to non-BRCA1/2 carriers in a large breast cancer cohort” AACR 2013; Abstract 1338.