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

Sponsor

Heinrich-Heine University, Duesseldorf (Other)

Overall Status

Unknown status

CT.gov ID

NCT00309920

Collaborator

(none)

1,234

Enrollment

Locations

26.3

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Biological: darbepoetin alfa Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Drug: fluorouracil	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1234 participants

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2004

Outcome Measures

Primary Outcome Measures

Disease-free survival at 6 months to 5 years after treatment []

Secondary Outcome Measures

Overall survival at 6 months to 5 years after treatment []
Toxicity by NCI toxicity criteria at every course and periodically thereafter []
Anemia and cognitive function by Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) at every course []
Local relapses at 6 months to 5 years after treatment []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Kreiskrankenhaus Aurich	Aurich	Germany	D-26603
2	Maria-Hilf-Krankenhaus	Bergheim	Germany	D-50126
3	Evangelisches Krankenhaus - Bergisch Gladbach	Bergisch	Germany	D-51465
4	Knappschaft Krankenhaus	Bochum-Langendreer	Germany	D-44892
5	Praxis fuer Haematologie - Onkologie	Bonn-Duisdorf	Germany	D-53123
6	Johanniter-Krankenhaus Bonn	Bonn	Germany	D-53113
7	Onkologische Gemeinschaftspraxis	Bonn	Germany	D-53119
8	St. Rochus Hospital	Castrop-Rauxel	Germany	D-44575
9	Praxis Fuer Haematologie Internistische Onkologie	Cologne	Germany	D-50677
10	Medizinische Universitaetsklinik I at the University of Cologne	Cologne	Germany	D-50924
11	St. Elisabeth-Krankenhaus - Koeln	Cologne	Germany	D-50935
12	Klinikum Deggendorf	Deggendorf	Germany	D-94469
13	Universitaetsklinikum Duesseldorf	Duesseldorf	Germany	D-40225
14	Onkologische Schwerpunktpraxis	Duisburg	Germany	D-47055
15	Alfried Krupp Krankenhaus	Essen	Germany	D-45117
16	Universitaetsklinikum Essen	Essen	Germany	D-45122
17	II Medizinische Klinik - Klinikum Fuerth	Fuerth	Germany	D-90766
18	Evangelische Kliniken Gelsenkirchen GmbH	Gelsenkirchen	Germany	D-45879
19	Wilhelm-Anton-Hospital gGmbH, Goch	Goch	Germany	D-47574
20	Maria-Josef-Hospital Greven GmbH	Greven	Germany	D-48268
21	Allgemeines Krankenhaus Hagen	Hagen	Germany	D-58095
22	Evangelisches Krankenhaus Hagen-Haspe GmbH	Hagen	Germany	D-58135
23	Henriettenstiftung Krankenhaus	Hannover	Germany	D-30171
24	Praxisgemeinschaft fuer Gynaekologische Onkologie	Hildesheim	Germany	D-31134
25	Universitaetsklinikum des Saarlandes	Homburg	Germany	D-66424
26	Klinikum Kaufbeuren Ostallgaeu	Kaufbeuren	Germany	D-87600
27	Katholisches Klinikum Koblenz Marienhof	Koblenz	Germany	D-56073
28	Frankenwald Klinik	Kronach	Germany	D-96317
29	Internistische Onkologische Praxis - Kronach	Kronach	Germany	D-96317
30	St. Marien Hospital - Luenen	Luenen	Germany	D-44534
31	St. Vincenz und Elisabeth Hospital	Mainz	Germany	D-55131
32	Klinikum Memmingen	Memmingen	Germany	D-87700
33	Klinikum Minden	Minden	Germany	D-32423
34	Krankenhaus Bethanien	Moers	Germany	D-47441
35	Marienhaus Klinikum St. Elisabeth Neuwied	Neuwied	Germany	D-56564
36	Evangelisches Krankenhaus Oberhausen	Oberhausen	Germany	D-46004
37	Internistische Gemeinschaftspraxis - Offenbach	Offenbach	Germany	D-63065
38	Praxis fuer Haematologie und Onkoligie	Rheine	Germany	D-48431
39	Klinikum Suedstadt Rostock	Rostock	Germany	D-18059
40	Marienkrankenhaus Schwerte gem. GmbH	Schwerte	Germany	D-58239
41	Staedtisches Klinikum Solingen	Solingen	Germany	D-42653
42	Praxis Fuer Internistische Haematologie / Onkologie	Troisdorf	Germany	D-53840
43	Katherinen-Hospital gGmbH	Unna	Germany	D-59423
44	Marien-Hospital Wesel gGmbH	Wesel	Germany	D-46483
45	Marien-Hospital Witten	Witten	Germany	D-58452
46	Bethesda Krankenhaus Wuppertal gGmbH	Wuppertal	Germany	D-42109
47	Haematologie / Onkologische Schwerpunktpraxis	Wuppertal	Germany	D-42275