Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer (LABC)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Gene Expression Signature and Immunohistochemical Markers Associated With Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer|
- Clinical objective and pathological responses to chemotherapy [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
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.
- Clinical, radiologic and pathologic correlation [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]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
- Surgery [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]The use and security of oncoplastic surgery after neoadjuvant chemotherapy
- Overall actuarial survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Pathologic complete response [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]Pathologic complete response after neoadjuvant chemotherapy
Biospecimen Retention: Samples With DNA
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||September 2017|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Clinical stage III
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)
4 cycles AC: doxorubicin 60mg/m2
Other Name: clinical and radiologic responseDrug: cyclophosphamide
4 cycles AC: cyclophosphamide 600mg/m2
Other Name: clinical and radiologic responseDrug: paclitaxel
4 cycles T: paclitaxel 175mg/m2 after 4 AC
Other Name: clinical, radiologic and pathologic responseProcedure: 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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820690
|Barretos Cancer Hospital|
|Barretos, São Paulo, Brazil, 14.784-400|
|Study Chair:||Maria Aparecida A Koike Folgueira, MD, PhD||Faculdade de Medicina - Universidade de São Paulo|