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Complete title: Intensive Trial of OMics in Cancer (ITOMIC) 001- Intensive Longitudinal Monitoring in Patients 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)
Genders Eligible for Study: Female
Patients with metastatic triple negative breast cancer treated at Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- Patients will have metastatic triple negative breast cancer (TNBC) and are about to receive treatment with single agent cisplatin
- Measurable disease including bone disease as determined by physical exam or imaging
- Patients must have tumor that is suitable for biopsy (as assessed by trained specialists 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); patients must be medically fit and willing to undergo repeated tissue biopsies or surgical procedures to get tumor tissue
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
- 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)
- Minorities are included in this protocol
- Patients with a prior history of malignancy remain eligible
- Patients with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome remain eligible
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- It is at the enrolling study oncologist's discretion to decide if a patient is not fit enough to undergo repeated tissue biopsies; presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
- Significant bleeding disorder
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- Inability to give informed consent
- Known brain metastases that haven't been treated
- Bevacizumab treatment within 4 weeks prior to biopsy
- Anticoagulation therapy, unless reversed at the time of biopsy
- Patients with a life expectancy of less than 6 months
- Prior treatment with platinum-based chemotherapy for TNBC
Other exclusion criteria may apply.
Breast Cancer; Solid Tumors; HER2-Negative
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