Clinical trial · Observational
Collecting, Analyzing, and Storing Samples From Patients With Metastatic, Triple Negative Breast Cancer Receiving Anti-cancer Therapy
Intensive Trial of OMics in Cancer (ITOMIC) - Intensive Longitudinal Monitoring in Subjects With Triple-Negative Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to loss of funding.
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Estrogen Receptor Negative | — | UNRESOLVED | — |
| HER2/Neu Negative | — | UNRESOLVED | — |
| Progesterone Receptor Negative | — | UNRESOLVED | — |
| Stage IV Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Triple-Negative Breast Carcinoma | Triple-Negative Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-Correlative (sample collection)
- description
- Patients undergo collection of tissue biopsy, blood, buccal swab, saliva, and urine at baseline.
- interventionNames
- Other: Cytology Specimen Collection Procedure
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (2)
- 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
- description
- The frequency of adverse events associated with multiple repeated study-related biopsies (or leukapheresis runs) will be determined using simple statistics.
- measure
- Infrastructure for acquiring, storing, retrieving and analyzing panomic data from clinical tumor specimens in a clinically relevant timeframe from participating sites
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 consentReferences
Publications (0)
Data not yet available