Clinical trial · Observational
A Prospective Longitudinal Breast Cancer Study
A Prospective Longitudinal Study of CA 15-3 as an Aid in Monitoring Recurrence or Progressive Disease in Patients With Breast Cancer
NCT02270931CI-TRIAL-00053317completedClinicalTrials.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)
The purpose of this study is to obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any stage of breast cancer.
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 |
|---|---|---|---|
| CA 15-3 Assay | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Measure CA 15-3 in Breast Cancer Patients
- timeFrame
- 3 years
- description
- 130 patients with Recurrence or Progressive Breast Cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males and females, age≥ 18 years * Histologic/pathologic confirmation of breast cancer * Any stage of disease: Newly diagnosed, stable, disease progression, surveillance * Any treatment time point: Treatment naïve, currently receiving or completed therapy for breast cancer including active monitoring. * Individuals with a history of malignant disease other than breast cancer that was resected greater than 5 years ago and are currently in remission are eligible. * Able to understand and willing to provide informed consent Exclusion Criteria: * Males and females, age \<18 years * No histologic/pathologic confirmation of breast cancer * Any concurrent malignancy other than basal or squamous cell skin cancers, in-situ cervical cancer, or breast cancer. * Treatment plan with fewer than three visits expected in 3 years' time * Unable to provide informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.