A Phase 2 interventional study of docetaxel and doxorubicin in Breast Cancer, sponsored by Hospital San Carlos, Madrid. Completed at 1 site in Spain. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-08-06.
Sponsored by Hospital San Carlos, Madrid · Phase 2, Interventional, and Treatment
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.
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).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 250 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hospital San Carlos, Madrid is the lead sponsor of 70 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
doxorubicin
Drug: doxorubicin
docetaxel
Drug: docetaxel
100 mg/m2 every 3 weeks times 4
Also known as: taxotere
75 mg/m2 every 3 weeks times 4
Also known as: adriamycin
correlation of genetic tumoral pattern with response to docetaxel versus doxorubicin
Time frame: 2005-2009
response rate to doxorubicin versus docetaxel
Time frame: 2005-2013
This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
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Hospital San Carlos, Madrid