This trial is active, not recruiting.

Condition breast cancer
Treatments doxorubicin, cyclophosphamide, paclitaxel, surgery
Sponsor Barretos Cancer Hospital
Collaborator University of Sao Paulo
Start date July 2008
End date April 2012
Trial size 80 participants
Trial identifier NCT00820690, 135/2008


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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)
doxorubicin clinical and radiologic response
4 cycles AC: doxorubicin 60mg/m2
cyclophosphamide clinical and radiologic response
4 cycles AC: cyclophosphamide 600mg/m2
paclitaxel clinical, radiologic and pathologic response
4 cycles T: paclitaxel 175mg/m2 after 4 AC
surgery Oncoplastic 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

Primary Outcomes

Clinical objective and pathological responses to chemotherapy
time frame: 8 months

Secondary Outcomes

Clinical, radiologic and pathologic correlation
time frame: 3 years
time frame: 5 years
Overall actuarial survival
time frame: 5 years
Pathologic complete response
time frame: 9 months

Eligibility Criteria

Female participants from 18 years up to 70 years old.

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

Additional Information

Official title Gene Expression Signature and Immunohistochemical Markers Associated With Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Barretos Cancer Hospital.