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Collecting, Analyzing, and Storing Samples From Patients With Metastatic, Triple Negative Breast Cancer Receiving Cisplatin (ITOMIC)

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
Phase       Pilot

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Research Study Description

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) and that has spread to other places in the body 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 deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Female

Study Population

Patients with metastatic triple negative breast cancer treated at Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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

- Prisoners

- 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.

Research Study Number       8132
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

Breast Cancer; Solid Tumors; HER2-Negative

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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.

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