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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00309920
• Other study ID #: CDR0000458037
• Secondary ID: WGSG-ARA-PLUSAVE
• Status: Recruiting
• Phase: N/A
• First received: March 29, 2006
• Last updated: February 6, 2009
• Start date: January 2004

Study information

• Verified date: April 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1234
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• darbepoetin alfa

Drug:
• cyclophosphamide

• docetaxel

• doxorubicin hydrochloride

• epirubicin hydrochloride

• fluorouracil

Locations

Country	Name	City	State
Germany	Kreiskrankenhaus Aurich	Aurich
Germany	Maria-Hilf-Krankenhaus	Bergheim
Germany	Evangelisches Krankenhaus - Bergisch Gladbach	Bergisch
Germany	Knappschaft Krankenhaus	Bochum-Langendreer
Germany	Johanniter-Krankenhaus Bonn	Bonn
Germany	Onkologische Gemeinschaftspraxis	Bonn
Germany	Praxis fuer Haematologie - Onkologie	Bonn-Duisdorf
Germany	St. Rochus Hospital	Castrop-Rauxel
Germany	Medizinische Universitaetsklinik I at the University of Cologne	Cologne
Germany	Praxis Fuer Haematologie Internistische Onkologie	Cologne
Germany	St. Elisabeth-Krankenhaus - Koeln	Cologne
Germany	Klinikum Deggendorf	Deggendorf
Germany	Universitaetsklinikum Duesseldorf	Duesseldorf
Germany	Onkologische Schwerpunktpraxis	Duisburg
Germany	Alfried Krupp Krankenhaus	Essen
Germany	Universitaetsklinikum Essen	Essen
Germany	II Medizinische Klinik - Klinikum Fuerth	Fuerth
Germany	Evangelische Kliniken Gelsenkirchen GmbH	Gelsenkirchen
Germany	Wilhelm-Anton-Hospital gGmbH, Goch	Goch
Germany	Maria-Josef-Hospital Greven GmbH	Greven
Germany	Allgemeines Krankenhaus Hagen	Hagen
Germany	Evangelisches Krankenhaus Hagen-Haspe GmbH	Hagen
Germany	Henriettenstiftung Krankenhaus	Hannover
Germany	Praxisgemeinschaft fuer Gynaekologische Onkologie	Hildesheim
Germany	Universitaetsklinikum des Saarlandes	Homburg
Germany	Klinikum Kaufbeuren Ostallgaeu	Kaufbeuren
Germany	Katholisches Klinikum Koblenz Marienhof	Koblenz
Germany	Frankenwald Klinik	Kronach
Germany	Internistische Onkologische Praxis - Kronach	Kronach
Germany	St. Marien Hospital - Luenen	Luenen
Germany	St. Vincenz und Elisabeth Hospital	Mainz
Germany	Klinikum Memmingen	Memmingen
Germany	Klinikum Minden	Minden
Germany	Krankenhaus Bethanien	Moers
Germany	Marienhaus Klinikum St. Elisabeth Neuwied	Neuwied
Germany	Evangelisches Krankenhaus Oberhausen	Oberhausen
Germany	Internistische Gemeinschaftspraxis - Offenbach	Offenbach
Germany	Praxis fuer Haematologie und Onkoligie	Rheine
Germany	Klinikum Suedstadt Rostock	Rostock
Germany	Marienkrankenhaus Schwerte gem. GmbH	Schwerte
Germany	Staedtisches Klinikum Solingen	Solingen
Germany	Praxis Fuer Internistische Haematologie / Onkologie	Troisdorf
Germany	Katherinen-Hospital gGmbH	Unna
Germany	Marien-Hospital Wesel gGmbH	Wesel
Germany	Marien-Hospital Witten	Witten
Germany	Bethesda Krankenhaus Wuppertal gGmbH	Wuppertal
Germany	Haematologie / Onkologische Schwerpunktpraxis	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival at 6 months to 5 years after treatment			No
Secondary	Overall survival at 6 months to 5 years after treatment			No
Secondary	Toxicity by NCI toxicity criteria at every course and periodically thereafter			Yes
Secondary	Anemia and cognitive function by Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) at every course			No
Secondary	Local relapses at 6 months to 5 years after treatment			No