Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer

Heinrich-Heine University, Duesseldorf

Status: Unknown

Conditions: Breast Cancer

Treatments: Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: docetaxel; Biological: darbepoetin alfa; Drug: epirubicin hydrochloride; Drug: fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT00309920

SANOFI-WGSF-ARA-PLUS

CDR0000458037

WGSG-ARA-PLUS

EU-205108

AVENTIS-WGSG-ARA-PLUS

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Colony-stimulating factors, such as darbepoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with darbepoetin alfa after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy and darbepoetin alfa are more effective than combination chemotherapy alone in treating stage III breast cancer.

PURPOSE: This randomized clinical trial is studying how well giving combination chemotherapy together with darbepoetin alfa works compared to combination chemotherapy alone in treating women with stage III breast cancer.

Full description

OBJECTIVES:

Primary

• Compare the disease-free survival rate in women with stage III breast cancer treated with adjuvant chemotherapy with vs without darbepoetin alfa.

Secondary

• Compare local recurrence and overall survival in patients receiving these regimens.
• Compare toxicity of these regimens in these patients.
• Compare quality of life and fatigue frequency in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according the chemotherapy regimen (CEF vs TAC). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive 1 of the following regimens:

  • Regimen CEF: Patients receive cyclophosphamide IV, epirubicin hydrochloride IV, and fluorouracil IV on day 1.
  • Regimen TAC: Patients receive docetaxel IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1.

Treatment repeats every 3 weeks for 6 courses in the absence of disease progression and unacceptable toxicity.

• Arm II: Patients receive 1 of the following regimens:

  • Regimen CEF: Patients receive regimen CEF as in arm I. Patients receive darbepoetin alfa if hemoglobin falls to ≤ 13.0 g/dL. Darbepoetin alfa is discontinued when hemoglobin rises to > 14.0 g/dL.
  • Regimen TAC: Patients receive TAC as in arm I and darbepoetin alfa as in arm II, regimen CEF.

Quality of life is assessed at baseline, before each chemotherapy course, at the completion of study therapy, and at 6 and 12 months.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 1,234 patients will be accrued for this study.

Enrollment: 1,234 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer

  • Stage III disease (pT1, N2-3, M0)
  • No metastatic disease by thoracic x-ray, full-body bone scan, and liver sonography

• No inflammatory disease or Paget's disease

• Disease completely resected (R0) and ≥ 10 axillary lymph nodes removed

  • Underwent surgery approximately 42 days ago
  • At least 9 positive lymph nodes
  • No prior sequential mastectomy

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Female
• Menopausal status not specified
• ECOG performance status 0-1
• WBC ≥ 3,500/mm^3
• Creatinine ≤ 1.4 mg/dL
• Platelet count ≥ 100,000/mm^3
• Bilirubin ≤ 2.0 mg/dL
• No pre-existing symptomatic peripheral neuropathy
• Not pregnant or nursing
• No hypersensitivity to darbepoetin alfa, epoetin alfa, or any of their components
• No other malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No participation in another clinical study
• No prior therapies that would preclude study participation