Patterns of Genetic Expression Associated to Sensibility to Doxorubicin Versus Docetaxel as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer
18 Years
75 Years
Female
Breast Cancer
Trial Information
Patterns of Genetic Expression Associated to Sensibility to Doxorubicin Versus Docetaxel as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer
The aim of the study is to define the genetic signature which predicts the response to
single drug doxorubicin versus docetaxel. 250 patients will be included. cDNA microarrays
will be produced and the genetic pattern will be correlated with the response to doxorubicin
and docetaxel. Secondary aim is the prediction of response by means of IHC determinations
(her2, ER, PgR, Ki67, protein TAU), FISH (topoisomerase II alpha, her2) and PCR
(topoisomerase II alpha).
Inclusion Criteria:
- Locally advanced, inoperable breast carcinoma or stage II not amenable to breast
preserving surgery (amendment introduced on november 2006)
- Signed informed consent
Exclusion Criteria:
- Age >75
- Cardiac disease; LEFT <50%
- Hyperbilirubinemia
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
correlation of genetic tumoral pattern with response to docetaxel versus doxorubicin
Outcome Time Frame:
2005-2009
Safety Issue:
No
Principal Investigator
Eduardo Diaz-Rubio, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Servicio de Oncologia Medica, Hospital Universitario San Carlos, Madrid, Spain
Authority:
Spain: Spanish Agency of Medicines
Study ID:
05/117
NCT ID:
NCT00123929
Start Date:
January 2005
Completion Date:
May 2009
Related Keywords:
- Breast Cancer
- breast cancer
- neoadjuvant chemotherapy
- genetic signature
- doxorubicin
- docetaxel
- Breast Neoplasms
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