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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00309920
First received: March 29, 2006
Last updated: February 6, 2009
Last verified: April 2006

March 29, 2006
February 6, 2009
January 2004
Not Provided
Disease-free survival at 6 months to 5 years after treatment [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00309920 on ClinicalTrials.gov Archive Site
  • Overall survival at 6 months to 5 years after treatment [ Designated as safety issue: No ]
  • Toxicity by NCI toxicity criteria at every course and periodically thereafter [ Designated as safety issue: Yes ]
  • Anemia and cognitive function by Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) at every course [ Designated as safety issue: No ]
  • Local relapses at 6 months to 5 years after treatment [ Designated as safety issue: No ]
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Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer
Adjuvant Therapy of Breast Cancer: Impact of Erythropoiesis Stimulating Factors on Event Free Survival High Risk Breast Cancer Treatment

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.

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.

Interventional
Not Provided
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Biological: darbepoetin alfa
  • Drug: cyclophosphamide
  • Drug: docetaxel
  • Drug: doxorubicin hydrochloride
  • Drug: epirubicin hydrochloride
  • Drug: fluorouracil
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1234
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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
Female
18 Years to 65 Years
No
Not Provided
Germany
 
NCT00309920
CDR0000458037, WGSG-ARA-PLUS, AVENTIS-WGSG-ARA-PLUS, SANOFI-WGSF-ARA-PLUS, EU-205108
Not Provided
Not Provided
Heinrich-Heine University, Duesseldorf
Not Provided
Study Chair: Ulrike Nitz, PhD Heinrich-Heine University, Duesseldorf
National Cancer Institute (NCI)
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP