Gene Expression Signature and Immunohistochemical Markers Associated With Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
Overview
- Phase
- N/A
- Intervention
- doxorubicin
- Conditions
- Breast Cancer
- Sponsor
- Barretos Cancer Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Clinical objective and pathological responses to chemotherapy
- Last Updated
- 10 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Clinical stage III
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)
Intervention: doxorubicin
Clinical stage III
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)
Intervention: cyclophosphamide
Clinical stage III
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)
Intervention: paclitaxel
Clinical stage III
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)
Intervention: Surgery
Outcomes
Primary Outcomes
Clinical objective and pathological responses to chemotherapy
Time Frame: 8 months
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.
Secondary Outcomes
- Surgery(5 years)
- Clinical, radiologic and pathologic correlation(3 years)
- Overall actuarial survival(5 years)
- Pathologic complete response(9 months)