Dose Dense Abraxane in Adjuvant Chemotherapy for Breast Cancer
Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Abraxane (Drug)
Sponsored by: Harold J. Burstein, MD, PhD
Official(s) and/or principal investigator(s):
Harold Burstein, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute
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.
Official title: Dose Dense AB1-007 (Abraxane) in Adjuvant Chemotherapy for Breast Cancer: A Feasibility Study
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To evaluate the feasibility and toxicity of Abraxane after chemotherapy as part of dose-dense adjuvant chemotherapy for breast cancer.
To evaluate the feasibility of administering Abraxane on a dose dense schedule without G-CSF support
to estimate the percentage of patients with various grades of hematologic toxicity, neurotoxicity, and other non-hematologic toxicity associated with dose-dense Abraxane
to evaluate quality of life.
- 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.
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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
- 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
Locations and Contacts
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
Massacusetts General Hospital, Boston, Massachusetts 02114, United States
Starting date: March 2006
Last updated: February 15, 2013