Breast Cancer Clinical Trial
— LABCOfficial title:
Gene Expression Signature and Immunohistochemical Markers Associated With Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
Verified date | August 2015 |
Source | Barretos Cancer Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | September 2017 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Brazil | Barretos Cancer Hospital | Barretos | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Barretos Cancer Hospital | University of Sao Paulo |
Brazil,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical objective and pathological responses to chemotherapy | 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. |
8 months | Yes |
Secondary | Clinical, radiologic and pathologic correlation | 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 | 3 years | Yes |
Secondary | Surgery | The use and security of oncoplastic surgery after neoadjuvant chemotherapy | 5 years | Yes |
Secondary | Overall actuarial survival | 5 years | Yes | |
Secondary | Pathologic complete response | Pathologic complete response after neoadjuvant chemotherapy | 9 months | Yes |
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