Collecting, Analyzing, and Storing Samples From Patients With Metastatic, Triple Negative Breast Cancer Receiving Anti-cancer Therapy

Intensive Trial of OMics in Cancer (ITOMIC) - Intensive Longitudinal Monitoring in Subjects With Triple-Negative Breast Cancer

This pilot research trial studies collecting, analyzing, and storing samples from patients with triple negative breast cancer (breast cancer cells that do not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 protein) that has spread to other places in the body receiving anti-cancer therapy. Studying samples of tissue, blood, buccal swab, saliva, and urine in the laboratory from patients receiving anti-cancer therapy may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

PRIMARY OBJECTIVES:

I. To establish the safety and feasibility of collecting, analyzing and storing clinically annotated panomic and other data from serially monitored subjects with metastatic triple negative breast cancer (TNBC) who receive care from up to ten oncology practices across the United States.

SECONDARY OBJECTIVES:

I. To determine whether molecular changes associated with resistance to treatment can be identified.

II. To understand subject perceptions regarding panomic data and its application to cancer treatment.

III. To apply other technologies to the characterization of subject tumors as they become available.

OUTLINE:

Patients undergo collection of tissue biopsy, blood, buccal mucosa, saliva, and urine at baseline. Additional biopsies may be performed prior to treatment change.

After completion of biopsy, patients are followed up at 1 day and 7 days. Patients will be followed indefinitely or for as long as they agree to be in the study, depending on the availability of resources.

Inclusion Criteria:

• Subjects have metastatic TNBC

• Disease suitable for analysis from either (a) or (b) below:

  • (a) Research biopsy

    • Tumor tissue, which can include bone disease, as determined by physical exam or imaging (as assessed by a trained specialist in radiology)
    • Must be collected before the subject receives treatment with a drug they have not received previously

  • (b) Standard of care biopsy

    • Tumor tissue available from a previous biopsy as standard of care (to be determined by the principal investigator [PI] or his designee)
    • Must have been collected before subject receives treatment with a drug they have not received previously
    • May begin treatment either after enrollment or within several weeks prior to enrollment

• Subjects must be medically fit and willing to undergo repeated tissue biopsies or surgical procedures to get tumor tissue

• Procedure-specific signed informed consent prior to initiation of any study-related procedures

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (or a Karnofsky performance status of >= 50%)

• Agree to allow their de-identified clinical and laboratory data to be posted to publicly available databases such as database of Genotypes and Phenotypes (dbGaP)

Exclusion Criteria:

• Bevacizumab treatment within 4 weeks prior to biopsy
• Anticoagulation therapy, unless reversed at the time of biopsy
• The enrolling study oncologist has decided that the subject is not fit enough to undergo repeated tissue biopsies
• Presence of a condition or abnormality that in the opinion of the enrolling investigator would compromise the safety of the subject or the quality of the data
• Significant bleeding disorder
• Known brain metastases that have not or will not be treated
• Subjects with a life expectancy of less than 6 months
• Prisoners
• Inability to give informed consent