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

HER2/Neu Negative Clinical Trial

— ITOMIC  

Official title:

Intensive Trial of OMics in Cancer (ITOMIC) - Intensive Longitudinal Monitoring in Subjects With Triple-Negative Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01957514
• Other study ID #: 8132
• Secondary ID: NCI-2013-01654IT
• Status: Terminated
• Start date: October 28, 2013
• Est. completion date: June 30, 2018

Study information

• Verified date: September 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Estrogen Receptor Negative
• HER2/Neu Negative
• Progesterone Receptor Negative
• Stage IV Breast Cancer AJCC v6 and v7
• Triple Negative Breast Neoplasms
• Triple-Negative Breast Carcinoma

Intervention

Other:
• Cytology Specimen Collection Procedure
Undergo tissue biopsy, blood, buccal mucosa, saliva, and urine collection
• Laboratory Biomarker Analysis
Correlative studies
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington
United States	Northwest Medical Specialties PLLC	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The frequency of adverse events associated with multiple repeated study-related biopsies (or leukapheresis runs) will be determined using simple statistics.	Within 1 week of biopsy
Primary	Infrastructure for acquiring, storing, retrieving and analyzing panomic data from clinical tumor specimens in a clinically relevant timeframe from participating sites	Findings of potential clinical significance will be included in the reports provided to subjects and oncologists. Similarly, as new information becomes available, information of significance to understanding a subject's tumor or germline genomes may become apparent.	Up to 2 years
Secondary	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	Subject perceptions regarding the value of panomic testing in predicting the optimal treatment for subjects with cancer and for predicting the risk for developing other inherited diseases will be collected.	Baseline to 2 years
Secondary	Develop process improvements	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.	Up to 2 years
Secondary	Development and improvement of infrastructure for storing and working with data from subject biopsies	Data from subjects will be used to test the infrastructure being developing and identify areas that need to be improved.	Up to 2 years
Secondary	Methods required to analyze and integrate data across subjects and with data from the public domain	Methods and software that can facilitate comparing data from subjects with that deposited in the public domain will be developed.	Up to 2 years
Secondary	Molecular changes associated with treatment response or resistance	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.	Up to 2 years
Secondary	Number or frequencies of biopsies or leukapheresis runs	Safety and feasibility data will be analyzed and the frequency, nature, and severity of adverse events will be summarized.	Up to 2 years
Secondary	Removal of any unnecessary biopsies or generation of redundant data	Data across biopsies taken from the same individual at the same time point will be compared to assess the need for multiple biopsies.	Up to 2 years