drugset / Trial / NCT00123929
Genetic Expression and Prediction of Response to Neoadjuvant Docetaxel or Doxorubicin in Locally Advanced Breast Cancer
Phase 2
Completed
250 enrolled
Hospital San Carlos, Madrid
UNC Lineberger Comprehensive Cancer Center · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-01
- Primary completion
- 2009-05
- Completion
- 2009-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 100 mg/m2 | — |
| Comparator | Doxorubicin | Other / unclassified | 75 mg/m2 | — |