Dose Dense Abraxane in Adjuvant Chemotherapy for Breast Cancer

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harold J. Burstein, MD, PhD
• Collaborators: Beth Israel Deaconess Medical Center; Celgene Corporation; Massachusetts General Hospital
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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