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Complete title: Intensive Trial of OMics in Cancer (ITOMIC) 001- Intensive Longitudinal Monitoring in Subjects with Triple Negative Breast Cancer
|Research Study Number||8132|
|Principal Investigator||Tony Blau, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Sexes Eligible for Study: Female
Patients with metastatic TNBC treated at Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- Subjects have metastatic TNBC and are about to receive treatment with a drug they have not received previously
- Disease suitable for biopsy including bone disease as determined by physical exam or imaging (as assessed by a trained specialist in radiology) or have tumor tissue available from a previous biopsy as standard of care (to be determined by the principal investigator [PI] or his designee)
- 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)
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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
- Inability to give informed consent
Other exclusion criteria may apply.
Breast Cancer; Solid Tumors; HER2-Negative; Triple Negative Breast Neoplasms
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