Evaluation of Specific Biomarkers in Primary Invasive Breast Cancer

Study Overview
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Brief Summary
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This study will examine specific biomarkers in primary invasive breast cancer and explore their correlation with patient outcome following standard neoadjuvant treatment.

Official Title
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A Prospective, Exploratory Observational Study Evaluating Specific Biomarkers in Primary Invasive Breast Cancer and Their Modulation by Standard Neoadjuvant Therapy

Conditions
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Neoplasms, Breast

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients with primary invasive breast cancer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of a specific predictive gene expression signature in tumor tissues |  | At randomization and at definitive surgery which may be up to 30 weeks post randomization. | 
| The presence of immune infiltration in tumor tissues |  | At randomization and at definitive surgery which may be up to 30 weeks post randomization. | 
| The presence of other candidate biomarkers in tumor tissues |  | At randomization and at definitive surgery which may be up to 30 weeks post randomization. | 
| The pathological response (complete response or partial response) in the breast. |  | At definitive surgery which may be up to 30 weeks post randomization. | 
| Disease free interval |  | Time from definitive surgery to the date of first recurrence of the disease up to maximally 6 years. | 
| Disease free survival |  | Time from definitive surgery to either the date of first recurrence of the disease or the date of death (whatever the cause), whichever occurs first, up to maximally 6 years. | 
| Overall survival |  | Time from definitive surgery to the date of death, irrespective of the cause of death. Patients still alive will be censored at the date of the last contact up to maximally 6 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumor antigens, observational, breast cancer, biomarkers, Neoadjuvant