Clinical trial NCT00820690: Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
Official title: Gene Expression Signature and Immunohistochemical Markers Associated With Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: neoadjuvant chemotherapy
advanced breast cancer
microarray
correlation analysis
oncoplastic surgery
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2009-01-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women breast cancer, clinical stage III; condition to chemotherapy with doxorubicin/cyclophosphamide and paclitaxel

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.

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

Primary outcomes:
measure: Clinical objective and pathological responses to chemotherapy
timeFrame: 8 months
Secondary outcomes:
measure: Clinical, radiologic and pathologic correlation
timeFrame: 3 years
measure: Surgery
timeFrame: 5 years
measure: Overall actuarial survival
timeFrame: 5 years
measure: Pathologic complete response
timeFrame: 9 months
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital
state: São Paulo
Study officials:
affiliation: Faculdade de Medicina - Universidade de São Paulo
name: Maria Aparecida A Koike Folgueira, MD, PhD
role: STUDY_CHAIR
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