Breast Cancer
Conditions
Keywords
breast cancer, neoadjuvant chemotherapy, genetic signature, doxorubicin, docetaxel
Brief summary
After a core biopsy of the tumor is obtained, patients with locally advanced breast cancer are randomized to receive 4 cycles of full dose doxorubicin (75 mg/m2 e3w) or docetaxel (100 mg/m2 e3w). After the fourth cycle, patients are submitted to surgery to ascertain pathological response. They then receive the opposite drug, hormones, Herceptin, and radiation as indicated.
Detailed description
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).
Interventions
DRUGdocetaxel
100 mg/m2 every 3 weeks times 4
DRUGdoxorubicin
75 mg/m2 every 3 weeks times 4
Sponsors
UNC Lineberger Comprehensive Cancer Center
Hospital San Carlos, Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| correlation of genetic tumoral pattern with response to docetaxel versus doxorubicin | 2005-2009 |
Secondary
| Measure | Time frame |
|---|---|
| response rate to doxorubicin versus docetaxel | 2005-2013 |
Countries
Spain
Outcome results
None listed