Patterns of Genetic Expression Associated to Sensibility to Doxorubicin Versus Docetaxel as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- doxorubicin
- Conditions
- Breast Cancer
- Sponsor
- Hospital San Carlos, Madrid
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- correlation of genetic tumoral pattern with response to docetaxel versus doxorubicin
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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).
Investigators
Eligibility Criteria
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
- •Cardiac disease; LEFT \<50%
- •Hyperbilirubinemia
Arms & Interventions
1
doxorubicin
Intervention: doxorubicin
2
docetaxel
Intervention: docetaxel
Outcomes
Primary Outcomes
correlation of genetic tumoral pattern with response to docetaxel versus doxorubicin
Time Frame: 2005-2009
Secondary Outcomes
- response rate to doxorubicin versus docetaxel(2005-2013)