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

NCT01957514 | Terminated DMC

• 5 other identifiers: 8132NCI-2013-01654ITOMIC-001UW13022RG1013004
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• 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

  Baseline to 2 years

• Develop process improvements

  Up to 2 years

• Development and improvement of infrastructure for storing and working with data from subject biopsies

  Up to 2 years

• Methods required to analyze and integrate data across subjects and with data from the public domain

  Up to 2 years

• Molecular changes associated with treatment response or resistance

  Up to 2 years

Study Arms (1)

Ancillary-Correlative (sample collection)

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

Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Cytology Specimen Collection Procedure OTHER

Undergo tissue biopsy, blood, buccal mucosa, saliva, and urine collection

Also known as: Cytologic Sampling

Ancillary-Correlative (sample collection)

Laboratory Biomarker Analysis OTHER

Correlative studies

Ancillary-Correlative (sample collection)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Ancillary-Correlative (sample collection)

Questionnaire Administration OTHER

Ancillary studies

Ancillary-Correlative (sample collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic TNBC treated at Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (2)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Northwest Medical Specialties PLLC

Tacoma, Washington, 98405, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, blood, buccal mucosa, saliva, urine

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhijun Duan

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 8, 2013
• Study Start: October 28, 2013
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

US (2)