Triple Negative Trial

Intensive Trial of OMics in Cancer (ITOMIC) - Intensive Longitudinal Monitoring in Patients with Triple-Negative Breast Cancer

Study Objectives

To establish the safety and feasibility of collecting, analyzing and storing clinically annotated panomic and other data from serially monitored patients with metastatic TNBC who receive care from up to ten oncology practices across the United States.

Treatment Information

Tumors will be localized by physical exam and imaging. Research samples will be collected and questionnaires will be completed. Patients will undergo the initial set of biopsies prior to the initiation of treatment with a drug they have not received previously. Biopsies will be obtained from multiple sites of disease and will be subjected to extensive testing prior to treatment, following completion of treatment and following subsequent therapies.

Treatment will be administered in accordance with standard-of-care until toxicities preclude further treatment or disease progression occurs. At the time of disease progression or disease recurrence, restaging will be performed according to standard-of-care and biopsies and molecular testing will be repeated. Results will be evaluated by our Omic Tumor Board (OTB). The OTB is a panel of physicians, scientists and other experts that will evaluate results and generate a report that will be provided to the patient’s oncologist. Reports will mention potential treatments based on clinically actionable findings. Patients will be asked to complete a follow-up survey. At the time of disease progression or drug toxicity, patients may also be asked to undergo additional biopsies, before and after treatments chosen by the patient’s oncologist. We plan to follow patients indefinitely or for as long as they agree to be in the study, depending on the availability of resources.

Patient Population

  • Females with Stage IV triple negative breast cancer
  • Patients must be at least 18 years of age
  • Patients have metastatic TNBC and are about to receive treatment with a drug they have not received previously
  • Disease suitable for biopsy including bone disease or have tumor tissue available from a previous biopsy
  • Patients must be medically fit and willing to undergo repeated tissue biopsies or surgical procedures to get tumor tissue.
  • No known brain metastases that have not or will not be treated
  • Patients with a life expectancy of less than 6 months

Number of Patients: 120

On-Site Study Visits

The study will include, minimally:

  • Screening period (typically 1 week)
  • Active study period (typically 12-20 weeks following the first biopsy)
  • Follow-up period (typically, 1 week)

Following completion of treatment, patients will be offered the opportunity to undergo additional biopsies prior to and following other anti-cancer therapies as determined by their oncologist.

We will assess patient perceptions regarding the number of biopsies required for this protocol in our follow-up survey, and will use this information, in conjunction with an analysis of our test results, to determine the optimal number of biopsies in future protocols.

Long-term Follow-up

Patients may withdraw at any time. We plan to follow patients indefinitely or for as long as they agree to be in the study, depending on the availability of resources.

Other Procedures During Study Visits

  • Have your regularly scheduled visits with your oncologist between the biopsy visits with a member of the study team if possible
  • Clinical information (such as changes in concomitant meds, physical exam, lab results from blood draws) may be collected as needed
  • 2-4 teaspoons (10-20 ml) of blood may be collected

ClinicalTrials.gov Identifier: NCT01957514

Contact Information: 253-306-0532