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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 29, 2006

Last Updated Date

February 6, 2009

Start Date ^ICMJE

January 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Disease-free survival at 6 months to 5 years after treatment [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00309920 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Adjuvant Therapy of Breast Cancer: Impact of Erythropoiesis Stimulating Factors on Event Free Survival High Risk Breast Cancer Treatment

Brief 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.

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1234

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00309920

Other Study ID Numbers ^ICMJE

CDR0000458037, WGSG-ARA-PLUS, AVENTIS-WGSG-ARA-PLUS, SANOFI-WGSF-ARA-PLUS, EU-205108

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Heinrich-Heine University, Duesseldorf

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Ulrike Nitz, PhD

Heinrich-Heine University, Duesseldorf

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2006

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

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