Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer | RxWiki

Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Breast Cancer
Intervention	Drug: doxorubicin Drug: cyclophosphamide Drug: paclitaxel Procedure: Surgery
Phase	N/A
Sponsor	Barretos Cancer Hospital
Responsible Party	Barretos Cancer Hospital
ClinicalTrials.gov Identifier	NCT00820690
First Received	January 9, 2009
Last Updated	March 30, 2014
Last verified	March 2014

Tracking Information[ + expand ][ + ]

First Received Date	January 9, 2009
Last Updated Date	March 30, 2014
Start Date	July 2008
Estimated Primary Completion Date	September 2017
Current Primary Outcome Measures	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.
Current Secondary Outcome Measures	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

Descriptive Information[ + expand ][ + ]

Brief Title	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
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.
Study Type	Observational
Study Phase	N/A
Study Design	Observational Model: Cohort, Time Perspective: Prospective
Condition	Breast Cancer
Intervention	Drug: doxorubicin 4 cycles AC: doxorubicin 60mg/m2 Other Names: clinical and radiologic responseDrug: cyclophosphamide 4 cycles AC: cyclophosphamide 600mg/m2 Other Names: clinical and radiologic responseDrug: paclitaxel 4 cycles T: paclitaxel 175mg/m2 after 4 AC Other Names: 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 Other Names: Oncoplastic surgery Mastectomy
Study Arm (s)	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)

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	80
Estimated Completion Date	September 2017
Estimated Primary Completion Date	April 2012
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
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Brazil

Administrative Information[ + expand ][ + ]

NCT Number	NCT00820690
Other Study ID Numbers	135/2008
Has Data Monitoring Committee	No
Information Provided By	Barretos Cancer Hospital
Study Sponsor	Barretos Cancer Hospital
Collaborators	University of Sao Paulo
Investigators	Study Chair: Maria Aparecida A Koike Folgueira, MD, PhD Faculdade de Medicina - Universidade de São Paulo
Verification Date	March 2014

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