Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer

Harold J. Burstein, MD, PhD

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Stage II Breast Cancer

Stage I Breast Cancer

Treatments

Drug: Darbepoetin Alfa

Drug: Doxorubicin

Drug: Pegfilgrastim

Drug: Paclitaxel

Drug: Cyclophosphamide

Study type

Interventional

Funder types

Other

Identifiers

NCT00146562

03-154

Details and patient eligibility

About

The main purpose of this study is to see if pegfilgrastim (Neulasta) is safe and useful in supporting people through dose-dense chemotherapy, and to see if a long-acting red blood cell growth factor, darbepoetin alfa(Aranesp) can reduce the need for blood transfusion in chemotherapy recipients.

Full description

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.

Enrollment

135 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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