NCT00820690

Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Barretos Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	doxorubicin	4 cycles AC: doxorubicin 60mg/m2
DRUG	cyclophosphamide	4 cycles AC: cyclophosphamide 600mg/m2
DRUG	paclitaxel	4 cycles T: paclitaxel 175mg/m2 after 4 AC
PROCEDURE	Surgery	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

Timeline

• Start date: 2008-07-01
• Primary completion: 2012-04-01
• Completion: 2017-09-01
• First posted: 2009-01-12
• Last updated: 2015-08-05

Locations

1 site across 1 country: Brazil