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A Phase II Study of Pegfilgrastim (Neulasta) and Darbepoetin Alfa (Aranesp) in Support of Dose-Dense Adjuvant Chemotherapy for Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer

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Trial Information

A Phase II Study of Pegfilgrastim (Neulasta) and Darbepoetin Alfa (Aranesp) in Support of Dose-Dense Adjuvant Chemotherapy for Breast Cancer


- Patients will receive chemotherapy every 2 weeks for up to 8 cycles (spread out of
approximately 16 weeks, total) of treatment. On the day of chemotherapy treatment
patients may receive an injection of darbepoetin alfa in addition to chemotherapy if
their red blood cell count is below normal levels.

- On the day after chemotherapy treatment, patients will receive an injection of
pegfilgrastim. There is one pegfilgrastim shot given per treatment cycle, for a total
of 8 injections. Once the patient has finished chemotherapy and the last of the
pegfilgrastim shots, their participation in this trial will be complete.

- While on this study the following procedures will be performed: a physical exam will be
done every 2 weeks, vital signs will be done every 2 weeks, and blood tests every 2
weeks.

- This study also involves a Quality of Life Questionnaire done at the beginning of study
treatment, at 2 months, 4 months, 6 months, and 1 year after starting the study
treatment.

- Patients will remain on this study unless they experience unacceptable side effects
from any of the treatment drugs.


Inclusion Criteria:



- Histologically or cytologically confirmed breast cancer clinical stage I, II or III
disease. Patients must be deemed of sufficient risk for tumor or recurrence

- Patients may receive the defined adjuvant chemotherapy treatment either following
definitive breast surgery or prior to definitive breast surgery

- 18 years of age or older

- ECOG performance status 0 or 1

- ANC > 1,500/uL

- Hemoglobin > 9 g/dL

- Platelets > 100,000/ul

- Total bilirubin less than or equal to ULN

- AST/ALT < 1.5 x ULN

- Creatinine within normal institutional limits

- PT/PTT < institutional upper limit of normal

- LVEF > 50%

Exclusion Criteria:

- Previous cytotoxic chemotherapy or therapeutic radiation therapy

- Pregnant or lactating women

- Receiving any other investigational agents

- Stage IV breast cancer

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to pegfilgrastim or darbepoetin

- Previous exposure to G-CSF or pegfilgrastim or to recombinant erythropoetin-related
growth factors.

- On antibiotics within 72 hours of registration

- Patients with immune deficiency who are at increased risk of lethal infections when
treated with marrow-suppressive therapy, or HIV-positive patients receiving
anti-retroviral therapy

- Sickle cell disease

- Known positive antibody response to any erythropoietic agent

- Known hematologic diseases

- Known history of hyperviscosity syndrome

- Patients on lithium

- RBC transfusion within past 4 weeks

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the rate of febrile neutropenia in women treated with dose-dense adjuvant chemotherapy receiving pegfilgrastim every 2 weeks.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Harold Burstein, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

03-154

NCT ID:

NCT00146562

Start Date:

July 2003

Completion Date:

May 2007

Related Keywords:

  • Breast Cancer
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • adjuvant chemotherapy
  • G-CSF
  • pegfilgrastim
  • darbepoetin alfa
  • Breast Neoplasms

Name

Location
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Faulkner Hospital Jamaica Plain, Massachusetts  02130
Lowell General Hospital Lowell, Massachusetts  01854
North Shore Cancer Center Peabody, Massachusetts  01960