Clinical Trials

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SCCA Breast Cancer Clinical Trials

Monitoring Patients with Triple Negative Breast Cancer (8132)
Intensive Trial of OMics in Cancer (ITOMIC) 001- Intensive Longitudinal Monitoring in Patients with Triple Negative Breast Cancer
Status Conditions Phase Study ID
Recruiting Breast Cancer; Solid Tumors Pilot Study 8132

This pilot research trial studies collecting, analyzing, and storing samples from patients with metastatic, triple negative breast cancer receiving cisplatin. Studying samples of tissue, blood, buccal swab, saliva, and urine in the laboratory from patients receiving cisplatin may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

Tony Blau, MD
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Patients will have metastatic triple negative breast cancer (TNBC) and are about to receive treatment with single agent cisplatin
  • Measurable disease as determined by physical exam or imaging
  • Patients must have tumor suitable for biopsy (as assessed by trained specialists in radiology); 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
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 tissue biopsy; 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
  • Prisoners
  • Inability to give informed consent
  • Untreated brain metastases
  • 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
Last Updated
March 03, 2014
See this trial at
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.