Clinical trial · Observational
Optimizing Treatment of Stage IV Breast Cancer Through Real-Time Disease Monitoring
Optimizing Treatment of Metastatic Breast Cancer Through Real-Time Disease Monitoring
NCT04906369CI-TRIAL-00114140suspendedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of funding
Summary
Brief summary (as posted)
This study evaluates if blood tests can detect changes in disease status during treatment for stage IV breast cancer. Information from this study may help researchers learn more about metastatic breast cancer and how to optimize treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage IV Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Metastatic Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
| Prognostic Stage IV Breast Cancer AJCC v8 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-Correlative (biospecimen collection)
- description
- Patients undergo collection of blood samples at baseline, 2 weeks after the start of treatment, and at the beginning of each new treatment cycle.
- interventionNames
- Procedure: Biospecimen Collection
Primary outcomes (2)
- measure
- Identification of patients with high circulating tumor-derived deoxyribonucleic acid (ctDNA) fractions (> 50%)
- timeFrame
- Up to 1 year
- description
- Will analyze across all three subtypes: Estrogen receptor positive (ER+), human epidermal growth factor receptor 2 positive (HER2+), and triple-negative breast cancer (TNBC). Will perform 30x whole genome sequencing (WGS) and generate subtype-specific pooled nucleosome occupancy maps. By comparing these maps with healthy volunteers, we will identify a set of loci across the genome most informative of cancer contribution in cell-free DNA (cfDNA).
- measure
- Detection of treatment failure
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults \> 18 years of age * Stage IV breast cancer undergoing cancer treatment Exclusion Criteria: * Stage I-III breast cancer * Unwilling or unable to give consent * Patients with a prior or concurrent malignancy, excluding non-melanoma skin cancers and non-invasive cancers whose natural history or treatment does not have the potential to interfere with the assessment of the investigational marker
References
Publications (0)
Data not yet available
No reference posted for this study.