Clinical trial NCT01957514: Collecting, Analyzing, and Storing Samples From Patients With Metastatic, Triple Negative Breast Cancer Receiving Anti-cancer Therapy
Official title: Intensive Trial of OMics in Cancer (ITOMIC) - Intensive Longitudinal Monitoring in Subjects With Triple-Negative Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Estrogen Receptor Negative
HER2/Neu Negative
Progesterone Receptor Negative
Stage IV Breast Cancer AJCC v6 and v7
Triple-Negative Breast Carcinoma
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic TNBC treated at Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Brief summary: 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.

Detailed description: PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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.

OUTLINE:

Patients undergo collection of tissue biopsy, blood, buccal mucosa, saliva, and urine at baseline. Additional biopsies may be performed prior to treatment change.

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

Eligibility criteria: Inclusion Criteria:

* Subjects have metastatic TNBC
* Disease suitable for analysis from either (a) or (b) below:

  * (a) Research biopsy

    * Tumor tissue, which can include bone disease, as determined by physical exam or imaging (as assessed by a trained specialist in radiology)
    * Must be collected before the subject receives treatment with a drug they have not received previously
  * (b) Standard of care biopsy

    * Tumor tissue available from a previous biopsy as standard of care (to be determined by the principal investigator \[PI\] or his designee)
    * Must have been collected before subject receives treatment with a drug they have not received previously
    * May begin treatment either after enrollment or within several weeks prior to enrollment
* 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 have not or will not be treated
* Subjects with a life expectancy of less than 6 months
* Prisoners
* Inability to give informed consent

Primary outcomes:
measure: Incidence of adverse events resulting from 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
timeFrame: Within 1 week of biopsy
measure: Infrastructure for acquiring, storing, retrieving and analyzing panomic data from clinical tumor specimens in a clinically relevant timeframe from participating sites
timeFrame: Up to 2 years
Secondary outcomes:
measure: 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
timeFrame: Baseline to 2 years
measure: Develop process improvements
timeFrame: Up to 2 years
measure: Development and improvement of infrastructure for storing and working with data from subject biopsies
timeFrame: Up to 2 years
measure: Methods required to analyze and integrate data across subjects and with data from the public domain
timeFrame: Up to 2 years
measure: Molecular changes associated with treatment response or resistance
timeFrame: Up to 2 years
measure: Number or frequencies of biopsies or leukapheresis runs
timeFrame: Up to 2 years
measure: Removal of any unnecessary biopsies or generation of redundant data
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties PLLC
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Zhijun Duan
role: PRINCIPAL_INVESTIGATOR
References: