Dose Dense Abraxane in Adjuvant Chemotherapy for Breast Cancer

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

The purpose of this trial is to see if Abraxane, which is a new form of paclitaxel, is safe as a replacement form of paclitaxel in dose-dense chemotherapy. This trial will also determine if using Abraxane will allow patients to receive treatment every two weeks without requiring injects of G-CSF, a white blood cell stimulating growth factor.

Key facts

Study ID

NCT00308178

Run by

Harold J. Burstein, MD, PhD

People needed

66

Starts

2006-03-01

Expected to finish

2008-06-01

Last updated by the study team

2013-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed breast cancer, with clinical stage I, II, or III disease
• Must register at the beginning of adjuvant or neoadjuvant chemotherapy
• 18 years of age or older
• ECOG performance status of 0 or 1
• Normal organ and marrow function

You may not qualify if…

• Previous cytotoxic chemotherapy or therapeutic radiation therapy for any reason
• Pregnant or nursing
• Receiving any other investigational agents
• Patients with Stage IV breast cancer
• Current grade II or greater peripheral neuropathy or prior history of grade II or greater neuropathy
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Immune deficiency when treated with marrow-suppressive therapy or HIV-positive patients receiving anti-retroviral therapy
• Patients with sickle cell disease
• Known history of hyperviscosity syndrome
• Patients on lithium

Where it is running

• Massacusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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