Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123929
Status:
COMPLETED
Last Update Posted:
2009-08-06
First Post:
2005-07-22
Brief Title:
Genetic Expression and Prediction of Response to Neoadjuvant Docetaxel or Doxorubicin in Locally Advanced Breast Cancer
Sponsor:
Hospital San Carlos Madrid
Organization:
Hospital San Carlos Madrid
Study Overview
Official Title:
Patterns of Genetic Expression Associated to Sensibility to Doxorubicin Versus Docetaxel as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgm2 e3w or docetaxel 100 mgm2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None