Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

• Conditions: Breast Cancer
• Interventions: Drug: doxorubicin; Drug: cyclophosphamide; Drug: paclitaxel; Procedure: Surgery

• Registration Number: NCT00820690
• Lead Sponsor: Barretos Cancer Hospital

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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-12
• Primary Completion: 2012-04
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-05
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clinical stage III	Surgery	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)
Clinical stage III	doxorubicin	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)
Clinical stage III	cyclophosphamide	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)
Clinical stage III	paclitaxel	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)

Primary Outcome Measures

Name	Time	Method
Clinical objective and pathological responses to chemotherapy	8 months	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.

Secondary Outcome Measures

Name	Time	Method
Surgery	5 years	The use and security of oncoplastic surgery after neoadjuvant chemotherapy
Clinical, radiologic and pathologic correlation	3 years	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
Overall actuarial survival	5 years
Pathologic complete response	9 months	Pathologic complete response after neoadjuvant chemotherapy

Trial Locations

Locations (1)

Barretos Cancer Hospital; 🇧🇷 Barretos, São Paulo, Brazil