Status:
COMPLETED
Dose Dense Abraxane in Adjuvant Chemotherapy for Breast Cancer
Lead Sponsor:
Harold J. Burstein, MD, PhD
Collaborating Sponsors:
Celgene Corporation
Beth Israel Deaconess Medical Center
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Abra...
Detailed Description
* Patients will receive regular chemotherapy every 2 weeks for up to 8 cycles (approximately 16 weeks total)of treatment. During the first four cycles patients will be treated with Adriamycin and Cyto...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00308178
Start Date
March 1 2006
End Date
June 1 2008
Last Update
February 18 2013
Active Locations (3)
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1
Massacusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215