Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy

Study Overview
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Brief Summary
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The primary aim of the study is to identify genomic markers (circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), transcriptomic markers) as biomarkers of response to neoadjuvant chemotherapy (NAC) among patients with invasive breast cancer.

Detailed Description
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The study aims to evaluate genetic markers (i.e. CTCs and ctDNA) in breast tumors to predict therapy response and metastatic risk. We aim to investigate genomic markers of treatment response and outcomes in breast cancer patients treated with neoadjuvant chemotherapy. The role of CTCs and ctDNA in predicting response to NAC will also be investigated.

Official Title
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Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy

Conditions
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Breast Cancer, Breast Neoplasms, Cancer, Breast

Intervention / Treatment
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* Diagnostic Test: Genomic Markers (CTC/ctDNA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must give appropriate written informed consent prior to participation in the study. Subjects must be women or men age 18+. Subjects must be receiving neoadjuvant chemotherapy for breast cancer. All chemotherapy types and regimens are acceptable (systemic therapy will determined by the overseeing medical oncologist). Biopsy-confirmed diagnosis of invasive breast cancer (i.e. ER+/-, PR+/-, HER2+/-). Stage I-III disease according to the AJCC v7 criteria. Exclusion Criteria: Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. silicone/saline implants) involving either breast, exclusive of the lesion at issue. Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety.

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Genomic Markers (CTC/ctDNA)|This is a non-interventional study.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic complete response (pCR) | Evaluating the degree of absence of residual cancer cells | Up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to distant breast cancer recurrence (months) | Evaluating the time until a recurrence event has occurred in the breast. | Up to 60 months | 
| Time to any recurrence (months) | Evaluating the time until a local, regional, or distant recurrence event has occurred. | Up to 60 months | 
| Time to death | Evaluating time to cancer-related death | Up to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circulating tumor cells, CTC, Circulating tumor DNA, ctDNA, Genomics, Transcriptomics