drugset / Trial / NCT00343512

Docetaxel Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer

NCT00343512 ↗

Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Dose-dense scheduling with (peg)filgrastim support may improve the clinical and pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant docetaxel therapy. PURPOSE: To evaluate whether dose-dense scheduling with (peg)filgrastim support may improve the clinical and pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant docetaxel therapy. To determine the changes in molecular markers that occurs with single agent docetaxel, tissue will be obtained at the end of the four cycles of docetaxel (either by repeat biopsy or definitive surgery).

Timeline

Start
2004-02
Primary completion
2008-03
Completion
2011-03

Outcome

Outcome not reported

Stopped: “closed due to competing neoadjuvant studies for a small patient population”

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 75 mg/m2 Intravenous

Indications