Clinical trial · Observational
Prospective Validation Trial of Circulating Tumor Cells (CTCs) in Women With Metastatic Breast Cancer
International Stage IV Stratification Study (ISSS): Prospective Validation Trial of Circulating Tumor Cells (CTCs) as Prognostic and Predictive Markers in Women With Metastatic Breast Cancer About to Start First-Line Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objectives: 1. To validate the prognostic significance of circulating tumor cells (CTCs) in patients with newly diagnosed metastatic breast cancer (MBC). 2. To prospectively determine if assessment of CTCs can be used to stratify patients with MBC into two prognostic groups independent of existing methods i.e. hormone-receptor status, site of metastasis (e.g. visceral vs. non visceral) and treatment administered (e.g. chemotherapy vs. hormonal therapy). 3. To incorporate this information into the current TNM staging system by sub-classifying stage IV disease into two prognostic groups, Stage IVA and Stage IVB. Secondary Objective: 1\. To perform global gene profiling on selected specimens and correlate the profiles with clinical outcomes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Sample | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Patients with newly diagnosed stage IV breast cancer scheduled to start systemic therapy.
- interventionNames
- Procedure: Blood Sample
Primary outcomes (1)
- measure
- To detect and count cancer cells in the blood of patients who have recently been diagnosed with a recurrent breast cancer.
- timeFrame
- 26 Months
Secondary outcomes (1)
- measure
- To learn if the detection of circulating cancer cells is a predictor for a worse disease prognosis.
- timeFrame
- 26 Months
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically or cytologically confirmed invasive breast cancer. Patients must have clinical and/or radiologic evidence of stage IV disease. Tumor may be of any hormone receptor type. * Patients must have newly diagnosed stage IV breast cancer that is scheduled to start a new systemic therapy. * Patients may have measurable or non-measurable disease. * Extent of disease will be determined by physical examination and imaging studies as per the primary physician. The tests utilized may include: (bone scans, PET/CT scans, CT of the abdomen, chest radiograph and/or CT of the chest for visceral metastases, sonogram and/or MRI for soft tissue disease). Patients with skin lesions will have photographs to evaluate their lesions. * ECOG performance status 0-2. * Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policies of the hospital. The only acceptable consent form is the one attached at the end of this protocol. Exclusion Criteria: * Patients with evidence of local regional recurrence only are excluded. * Patients who have received prior therapy for their metastatic breast disease. * Patients with known evidence of brain metastases (unless previously treated or stable) or carcinomatous meningitis. * Patients with history of any prior malignancies that have not been disease-free for at least 5 years prior to study entry. * Patients unwilling or unable to give consent. * Patients unwilling or unable to provided follow-up on their condition.
References
Publications (0)
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