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Gene Expression Signature and Immunohistochemical Markers Associated With Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer


N/A
18 Years
70 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Gene Expression Signature and Immunohistochemical Markers Associated With Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Clinical objective and pathological responses to chemotherapy

Outcome Time Frame:

8 months

Safety Issue:

Yes

Principal Investigator

Maria Aparecida A Koike Folgueira, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Faculdade de Medicina - Universidade de São Paulo

Authority:

Brazil: Ethics Committee

Study ID:

135/2008

NCT ID:

NCT00820690

Start Date:

October 2008

Completion Date:

September 2014

Related Keywords:

  • Breast Cancer
  • neoadjuvant chemotherapy
  • advanced breast cancer
  • microarray
  • correlation analysis
  • oncoplastic surgery
  • Breast Neoplasms

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