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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heinrich-Heine University, Duesseldorf
• Treatments: Cyclophosphamide; Darbepoetin alfa; Docetaxel; Doxorubicin; Epirubicin; Fluorouracil; Liposomal doxorubicin

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