Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer (LABC)

Barretos Cancer Hospital

Status: Unknown

Conditions: Breast Cancer

Treatments: Drug: doxorubicin; Drug: paclitaxel; Procedure: Surgery; Drug: cyclophosphamide

Study type: Observational

Funder types: Other

Identifiers

NCT00820690

135/2008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Clinical stage III

Description:

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)

Treatment:

Drug: cyclophosphamide

Procedure: Surgery

Drug: paclitaxel

Drug: doxorubicin