Dose Dense Abraxane in Adjuvant Chemotherapy for Breast Cancer

Harold J. Burstein, MD, PhD

Status

Completed

Conditions

Breast Cancer

Treatments

Drug: Abraxane

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00308178

05-249

Details and patient eligibility

About

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.

Full 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 Cytoxan, and for the second four cycles they will be treated with Abraxane.
Patients will be taught to give themselves injections with either short or long acting G-CSF as prescribed by their doctor for the first four cycles of chemotherapy. During the last four cycles (while the patient is taking Abraxane) they will not receive G-CSF unless they have low blood counts.
If the patient has HER-2 positive breast cancer, they will also receive 52 weeks of Herceptin as part of standard cancer care and will begin to receive Herceptin at the same time they begin Abraxane (after 4 cycles of adriamycin and cytoxan treatment).
This study involves a series of Quality of Life Questionnaires that will be completed prior to beginning study treatment, then again at 2 months, 4 months, 6 months, and 1 year after starting study treatment.
The following tests and procedures will be performed at the time periods specified. Cycle 1-4 Day 1: Physical exam, vital signs, and blood tests. Cycle 5 Day 1: Physical exam, vital signs, blood tests, RVG (measurement of heart function) and questionnaire. Cycle 6 & 7 Day 1: Physical exam, vital signs, and blood tests. Cycle 8 Day 1: physical exam, vital signs, blood tests, questionnaire. Follow-up (6 months and 1 year after cycle 1 day 1): questionnaire.

Enrollment

66 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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