Clinical trial · Observational
Evaluation of Specific Biomarkers in Primary Invasive Breast Cancer
A Prospective, Exploratory Observational Study Evaluating Specific Biomarkers in Primary Invasive Breast Cancer and Their Modulation by Standard Neoadjuvant Therapy
NCT01476111CI-TRIAL-00017073terminatedClinicalTrials.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): Study termination due to negative Phase III of another study product from same technology platform.
Summary
Brief summary (as posted)
This study will examine specific biomarkers in primary invasive breast cancer and explore their correlation with patient outcome following standard neoadjuvant treatment.
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 |
|---|---|---|---|
| Neoplasms, Breast | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- description
- Patients with primary invasive breast cancer
Primary outcomes (7)
- measure
- The presence of a specific predictive gene expression signature in tumor tissues
- timeFrame
- At randomization and at definitive surgery which may be up to 30 weeks post randomization.
- measure
- The presence of immune infiltration in tumor tissues
- timeFrame
- At randomization and at definitive surgery which may be up to 30 weeks post randomization.
- measure
- The presence of other candidate biomarkers in tumor tissues
- timeFrame
- At randomization and at definitive surgery which may be up to 30 weeks post randomization.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The patient has 18 years of age or older at the time of consent. * The patient has provided pre-treatment tumor samples for WT1 expression screening and gene expression profiling in the context of the NCT01220128 study. * The patient has a histologically or cytologically confirmed primary invasive breast cancer. * The patient has provided written informed consent before any new information or new material is provided to the Sponsor. * The patient is planned to receive, is receiving or has received standard and/or investigational therapy for breast cancer. * The patient is planned to receive, is receiving or has received standard and/or investigational therapy for breast cancer. Exclusion Criteria: Not applicable.
References
Publications (0)
Data not yet available
No reference posted for this study.