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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01957514
First received: September 30, 2013
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Estrogen Receptor-negative Breast Cancer
HER2-negative Breast Cancer
Progesterone Receptor-negative Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Triple-negative Breast Cancer
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intensive Trial of OMics in Cancer (ITOMIC) - Intensive Longitudinal Monitoring in Patients With Triple-Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Safety of performing multiple biopsies over time measured by the presence of biopsy-related complications, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v)4.0 [ Time Frame: Within 1 week of biopsy ] [ Designated as safety issue: Yes ]
  • Infrastructure for acquiring, storing, retrieving and analyzing panomic data from clinical tumor specimens in a clinically relevant timeframe [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number or frequencies of biopsies or leukapheresis runs [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
  • Molecular changes associated with treatment response or resistance [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Development and improvement of infrastructure for storing and working with data from patient biopsies [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Removal of any unnecessary biopsies or generation of redundant data [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Methods required to analyze and integrate data across patients and with data from the public domain [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Change in patient perceptions regarding panomic data and its application to cancer treatment [ Time Frame: Baseline to 2 years ] [ Designated as safety issue: No ]
  • Develop process improvements by monitoring the yield of successfully performing various types of analyses from biopsy specimens as well as the time frame necessary for returning reports to patients and their oncologists [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tissue, blood, buccal mucosa, saliva, urine


Estimated Enrollment: 20
Study Start Date: October 2013
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ancillary-Correlative (sample collection)
Patients undergo collection of tissue biopsy, blood, buccal swab, saliva, and urine at baseline.
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To establish the safety and feasibility of collecting, analyzing and storing panomic and other data from serially monitored patients with cancer in a manner that is scientifically useful.

SECONDARY OBJECTIVES:

I. To determine whether genetic changes associated with cisplatin resistance can be identified, to explore patient perceptions regarding panomic data and its application to cancer treatment, and to apply other technologies to the characterization of patient tumors as they become available.

OUTLINE:

Patients undergo collection of tissue biopsy, blood, buccal mucosa, saliva, and urine at baseline.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01957514

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Anthony Blau    206-685-6873      
Principal Investigator: Anthony Blau         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Anthony Blau Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01957514     History of Changes
Other Study ID Numbers: 8132, NCI-2013-01654, ITOMIC-001, UW13022, 8132, P30CA015704
Study First Received: September 30, 2013
Last Updated: June 9, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014