Breast Cancer
Conditions
Keywords
neoadjuvant chemotherapy, advanced breast cancer, microarray, correlation analysis, oncoplastic surgery
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.
Interventions
DRUGdoxorubicin
4 cycles AC: doxorubicin 60mg/m2
DRUGcyclophosphamide
4 cycles AC: cyclophosphamide 600mg/m2
DRUGpaclitaxel
4 cycles T: paclitaxel 175mg/m2 after 4 AC
PROCEDURESurgery
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
Sponsors
University of Sao Paulo
Barretos Cancer Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical objective and pathological responses to chemotherapy | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical, radiologic and pathologic correlation | 3 years | 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 |
| Surgery | 5 years | The use and security of oncoplastic surgery after neoadjuvant chemotherapy |
| Overall actuarial survival | 5 years | — |
| Pathologic complete response | 9 months | Pathologic complete response after neoadjuvant chemotherapy |
Countries
Brazil
Outcome results
None listed