Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to analyze gene expression signature and immunohistochemical markers associated with clinical and pathological response to neoadjuvant chemotherapy in locally advanced breast cancer.

Detailed Description
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Locally advanced breast cancer is a common condition in development countries. Neoadjuvant chemotherapy gives the opportunity to identify genetic signatures associated with objective clinical and pathological complete responses. Patients will receive doxorubicin/cyclophosphamide with paclitaxel. Tumor samples collected before and after chemotherapy will be analyzed.

Official Title
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Gene Expression Signature and Immunohistochemical Markers Associated With Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: doxorubicin
* Drug: cyclophosphamide
* Drug: paclitaxel
* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with locally advanced women breast cancer Histology: ductal ou lobular invasive histology Agreement to take part in the study and signature of the informed consent Clinical condition to receive doxorubicin/cyclophosphamide and paclitaxel ECOG 0 or I Exclusion Criteria: Not clinical stage III Inflammatory breast cancer Previous treatment Previous diagnosis of cancer (except basal cell or squamous cell skin carcinoma and non-invasive cervical carcinoma) Pregnancy Absence of clinical condition to receive chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| Clinical stage III<br>Women with invasive breast cancer; clinical stage III, condition to receive neoadjuvant chemotherapy based in doxorubicin/ cyclophosphamide and paclitaxel followed by surgery (mastectomy and axillary lymph node dissection) | Drug: doxorubicin<br>* 4 cycles AC: doxorubicin 60mg/m2<br>* Other names: clinical and radiologic response;Drug: cyclophosphamide<br>* 4 cycles AC: cyclophosphamide 600mg/m2<br>* Other names: clinical and radiologic response;Drug: paclitaxel<br>* 4 cycles T: paclitaxel 175mg/m2 after 4 AC<br>* Other names: clinical, radiologic and pathologic response;Procedure: Surgery<br>* The surgery will be performed 30 days after the chemotherapy. The correlation between clinical, radiologic and pathologic response will be reported. The oncoplastic surgery rate will be reported<br>* Other names: Mastectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical objective and pathological responses to chemotherapy | Clinical and radiological examinations to be performed before chemotherapy, after the 4 cycle of AC and before surgery. Pathologic evaluation to be performed 30 days after the last cycle of chemotherapy, i.g. after surgery. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical, radiologic and pathologic correlation | tumor concordance measurement among pre-operative physical examination (PE), mammography (MG), ultrasound (US), breast MRI and post-operative pathologic measurement concordance with PE, MG, US and MRI | 3 years | 
| Surgery | The use and security of oncoplastic surgery after neoadjuvant chemotherapy | 5 years | 
| Overall actuarial survival |  | 5 years | 
| Pathologic complete response | Pathologic complete response after neoadjuvant chemotherapy | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neoadjuvant chemotherapy, advanced breast cancer, microarray, correlation analysis, oncoplastic surgery