Dose Dense AB1-007 (Abraxane) in Adjuvant Chemotherapy for Breast Cancer: A Feasibility Study
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the feasibility and toxicity of Abraxane after chemotherapy as part of dose-dense adjuvant chemotherapy for breast cancer.
Harold Burstein, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massacusetts General Hospital||Boston, Massachusetts 02114|