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Collecting, Analyzing, and Storing Samples From Patients With Metastatic, Triple Negative Breast Cancer Receiving Anti-cancer Therapy (ITOMIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of Washington
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington Identifier:
First received: September 30, 2013
Last updated: October 24, 2016
Last verified: October 2016
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) that has spread to other places in the body receiving anti-cancer therapy. Studying samples of tissue, blood, buccal swab, saliva, and urine in the laboratory from patients receiving anti-cancer therapy may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Condition Intervention
Estrogen Receptor Negative
HER2/Neu Negative
Progesterone Receptor Negative
Stage IV Breast Cancer
Triple-Negative Breast Carcinoma
Other: Cytology Specimen Collection Procedure
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration

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 Subjects With Triple-Negative Breast Cancer

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Infrastructure for acquiring, storing, retrieving and analyzing panomic data from clinical tumor specimens in a clinically relevant timeframe from participating sites [ Time Frame: Up to 2 years ]
  • Safety of performing multiple biopsies measured by the presence of biopsy-related complications, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: Within 1 week of biopsy ]

Secondary Outcome Measures:
  • Change in subject perceptions regarding panomic data and its application to cancer treatment assessed by Intensive Trial of OMics in Cancer baseline and follow up questionnaires [ Time Frame: Baseline to 2 years ]
  • Develop process improvements [ Time Frame: Up to 2 years ]
    The yield of successfully performing various types of analyses from clinically indicated- and study-related biopsies and leukapheresis specimens as well as the time frame necessary for returning reports will be monitored.

  • Development and improvement of infrastructure for storing and working with data from subject biopsies [ Time Frame: Up to 2 years ]
    Data from subjects will be used to test the infrastructure being developing and identify areas that need to be improved.

  • Methods required to analyze and integrate data across subjects and with data from the public domain [ Time Frame: Up to 2 years ]
    Methods and software that can facilitate comparing data from subjects with that deposited in the public domain will be developed.

  • Molecular changes associated with treatment response or resistance [ Time Frame: Up to 2 years ]
    A number of statistical approaches will be used. Will be evaluated by comparing biopsies taken from the same subject pre- and post- anti-cancer treatment, and relating these changes to each subject's outcome.

  • Number or frequencies of biopsies or leukapheresis runs [ Time Frame: Up to 2 years ]
    Safety and feasibility data will be analyzed and the frequency, nature, and severity of adverse events will be summarized.

  • Removal of any unnecessary biopsies or generation of redundant data [ Time Frame: Up to 2 years ]

Biospecimen Retention:   Samples With DNA
Tissue, blood, buccal mucosa, saliva, urine

Estimated Enrollment: 120
Study Start Date: October 2013
Estimated Primary Completion Date: November 2018 (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: Cytology Specimen Collection Procedure
Undergo tissue biopsy, blood, buccal mucosa, saliva, and urine collection
Other Name: Cytologic Sampling
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary studies

Detailed Description:


I. To establish the safety and feasibility of collecting, analyzing and storing clinically annotated panomic and other data from serially monitored subjects with triple negative breast cancer metastatic triple negative breast cancer (TNBC) who receive care from up to ten oncology practices across the United States.


I. To determine whether molecular changes associated with resistance to treatment can be identified.

II. To understand subject perceptions regarding panomic data and its application to cancer treatment.

III. To apply other technologies to the characterization of subject tumors as they become available.


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

After completion of study, patients are followed up at 1 day, 7 days, and 30 days. Patents will be followed indefinitely or for as long as they agree to be in the study, depending on the availability of resources.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Bevacizumab treatment within 4 weeks prior to biopsy
  • 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 haven't been treated
  • Subjects with a life expectancy of less than 6 months
  • Prisoners
  • Inability to give informed consent
  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 identifier: NCT01957514

United States, Arkansas
Highlands Oncology Group PA - Fayetteville Not yet recruiting
Fayetteville, Arkansas, United States, 72703
Contact: J. Thaddeus Beck    479-872-8130      
Principal Investigator: J. Thaddeus Beck         
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Anthony Blau    206-685-6873   
Principal Investigator: Anthony Blau         
Northwest Medical Specialties PLLC Recruiting
Tacoma, Washington, United States, 98405
Contact: Sibel Blau    253-428-8700   
Principal Investigator: Sibel Blau         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Anthony Blau Fred Hutch/University of Washington Cancer Consortium
  More Information

Responsible Party: University of Washington Identifier: NCT01957514     History of Changes
Other Study ID Numbers: 8132
NCI-2013-01654 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
8132 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( US NIH Grant/Contract Award Number )
Study First Received: September 30, 2013
Last Updated: October 24, 2016

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on April 26, 2017