Clinical trial · Observational
ACT-MBC: A Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer (MBC)
ACT-MBC: A Prospective Observational Impact Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer
NCT05662345CI-TRIAL-00105745ACT-MBCactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
ACT-MBC prospectively assesses the impact of CTCs on treatment decisions, response assessment and prognosis in MBC patients.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CellSearch Circulating Tumor Cells | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To prospectively evaluate the impact of CellSearch CTCs on treatment decisions and response assessment in MBC patients
- timeFrame
- 3 to 4 months
- description
- Assessing proportion of providers that find CellSearch CTCs helpful in determining response to therapy in each unique patient (Questionnaire #2).
Secondary outcomes (2)
- measure
- Assess barriers and receptiveness of providers in using CTCs in clinical practice
- timeFrame
- 18 months
- description
- Assessing provider perception of the general usefulness of CTC in pre and post-intervention surveys (Questionnaire #1 and #3)
- measure
- Evaluate if CTC results correlate with response assessment and disease progression defined by standard of care imaging
- timeFrame
- 18 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease 2. ER+/HER2- patients prior to starting 2nd line therapy or beyond OR ER/Progesterone Receptor (PR)/HER2-negative (Triple Negative) patients prior to starting any line of therapy 3. Measurable and/or non-measurable disease is allowed 4. Male or female breast cancer is allowed 5. Age \> 18 years 6. Willingness to provide mandatory blood specimens 7. Willing to return to enrolling institution for follow up imaging at least once Exclusion Criteria: 1. Life expectancy of ≤ 6 months 2. Inability to provide blood samples based on the judgment of the treating provider
References
Publications (0)
Data not yet available
No reference posted for this study.