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Dose Dense AB1-007 (Abraxane) in Adjuvant Chemotherapy for Breast Cancer: A Feasibility Study

18 Years
Not Enrolling
Breast Cancer

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Trial Information

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the feasibility and toxicity of Abraxane after chemotherapy as part of dose-dense adjuvant chemotherapy for breast cancer.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Harold Burstein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

March 2006

Completion Date:

June 2008

Related Keywords:

  • Breast Cancer
  • Abraxane
  • dose-dense chemotherapy
  • taxol
  • Breast Neoplasms



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massacusetts General HospitalBoston, Massachusetts  02114