Adjuvant Therapy for High-Risk Localized Breast Cancer Using Weekly Adriamycin + Daily Oral Cytoxan With Continuous G-CSF Support for 12 Weeks Followed by Weekly Abraxane™ for 12 Weeks With Concurrent Herceptin for Subjects With HER-2/Neu Positive Disease, Phase II
PRIMARY OBJECTIVES:
I. To assess disease-free survival following a dose-intensive weekly regimen of Adriamycin +
oral cyclophosphamide augmented with G-CSF support followed by Abraxane and Herceptin if
appropriate for adjuvant treatment of high risk breast cancer patients.
SECONDARY OBJECTIVES:
I. To assess the toxicity associated with this regimen. II. To assess the delivered dose
intensity of the regimen. III. To assess time to treatment failure and overall survival of
the regimen. IV. To assess the incidence and severity of delayed nausea and vomiting with
this regimen.
OUTLINE:
Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over
10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim
subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of
disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive
paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12
weeks in the absence of disease progression or unacceptable toxicity. Patients with
HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1
year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 2 years, and then annually thereafter.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival following a dose-intensive weekly regimen of Adriamycin + oral cyclophosphamide augmented with G-CSF support followed by Abraxane and Herceptin
2 years
No
Georgiana Ellis
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
6141
NCT00407888
May 2006
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |