drugset
drugset / Trial / NCT00256243

Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer

NCT00256243 ↗

Phase 2 Completed 48 enrolled Rita Sanghvi, Mehta
NaSingle-groupOpen-labelTreatment

Summary

We proposed to use 4 cycles of AC q 2 weeks, as used in the dose dense adjuvant study with GM-CSF support on days 3-9 of the cycle. After the completion of AC we plan to administer paclitaxel and carboplatin weekly for a total of 12 doses with one week rest after every 3 weeks of treatment over 12 weeks. Patients who are her-2 over-expressors by FISH (fluorescence in situ hybridization) will also receive Trastuzumab with weekly carboplatin and paclitaxel as the combination TC±H has been found to be synergistic in advanced breast cancer with improved clinical outcome.

Timeline

Start
2004-04
Primary completion
2011-03
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab Monoclonal antibody 2 unknown Intravenous
Background Carboplatin Small molecule 2 unknown Intravenous
Background Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Background GM-CSF Protein / enzyme biologic 250 ug/ml Intravenous
Background Paclitaxel Small molecule 80 mg/m2 Intravenous

Indications

breast cancer