Trials / Completed

CompletedNCT00407888

Doxorubicin Hydrochloride, Cyclophosphamide, and Filgrastim Followed By Paclitaxel Albumin-Stabilized Nanoparticle Formulation With or Without Trastuzumab in Treating Patients With Breast Cancer Previously Treated With Surgery

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

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 60 (actual)

Sponsor: University of Washington · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as filgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy and filgrastim together with trastuzumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride, cyclophosphamide, and filgrastim together followed by paclitaxel albumin-stabilized nanoparticle formulation and trastuzumab works in treating patients with breast cancer previously treated with surgery

Detailed description

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.

Conditions

Interventions

Type	Name	Description
DRUG	doxorubicin hydrochloride	Given IV
DRUG	cyclophosphamide	Given orally
BIOLOGICAL	filgrastim	Given SC
DRUG	paclitaxel albumin-stabilized nanoparticle formulation	Given IV
BIOLOGICAL	trastuzumab	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
PROCEDURE	quality-of-life assessment	Ancillary studies

Timeline

Start date: 2006-05-01
Primary completion: 2009-05-01
Completion: 2012-07-01
First posted: 2006-12-05
Last updated: 2017-08-31
Results posted: 2017-08-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00407888. Inclusion in this directory is not an endorsement.