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
Recruitment status was Recruiting
Sponsor:
Heinrich-Heine University, Duesseldorf
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
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Purpose
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 | Intervention |
|---|---|
|
Breast Cancer |
Biological: darbepoetin alfa Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Drug: fluorouracil |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Cyclophosphamide
Fluorouracil
Doxorubicin
Doxorubicin hydrochloride
Epirubicin hydrochloride
Epirubicin
Docetaxel
Darbepoetin Alfa
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Disease-free survival at 6 months to 5 years after treatment [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 1234 |
| Study Start Date: | January 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309920
Locations
| Germany | |
| Kreiskrankenhaus Aurich | Recruiting |
| Aurich, Germany, D-26603 | |
| Contact: Contact Person 49-41-94-1802 | |
| Maria-Hilf-Krankenhaus | Recruiting |
| Bergheim, Germany, D-50126 | |
| Contact: Contact Person 49-2271-87-0 | |
| Evangelisches Krankenhaus - Bergisch Gladbach | Recruiting |
| Bergisch, Germany, D-51465 | |
| Contact: Contact Person 49-2202-122-497 | |
| Knappschaft Krankenhaus | Recruiting |
| Bochum-Langendreer, Germany, D-44892 | |
| Contact: Contact Person 49-234-299-3300 | |
| Johanniter-Krankenhaus Bonn | Recruiting |
| Bonn, Germany, D-53113 | |
| Contact: Contact Person 49-228-543-2401 | |
| Onkologische Gemeinschaftspraxis | Recruiting |
| Bonn, Germany, D-53119 | |
| Contact: Contact Person 49-228-908-1900 | |
| Praxis fuer Haematologie - Onkologie | Recruiting |
| Bonn-Duisdorf, Germany, D-53123 | |
| Contact: Contact Person 49-228-644-546 | |
| St. Rochus Hospital | Recruiting |
| Castrop-Rauxel, Germany, D-44575 | |
| Contact: Contact Person 49-2305-294-250 | |
| Medizinische Universitaetsklinik I at the University of Cologne | Recruiting |
| Cologne, Germany, D-50924 | |
| Contact: Contact Person 49-221-478-4940 | |
| Praxis Fuer Haematologie Internistische Onkologie | Recruiting |
| Cologne, Germany, D-50677 | |
| Contact: Contact Person 49-221-931-8220 | |
| St. Elisabeth-Krankenhaus - Koeln | Recruiting |
| Cologne, Germany, D-50935 | |
| Contact: Contact Person 49-221-4677-0-521 | |
| Klinikum Deggendorf | Recruiting |
| Deggendorf, Germany, D-94469 | |
| Contact: Contact Person 49-991-380-3172 | |
| Universitaetsklinikum Duesseldorf | Recruiting |
| Duesseldorf, Germany, D-40225 | |
| Contact: Contact Person 49-211-811-7550 | |
| Onkologische Schwerpunktpraxis | Recruiting |
| Duisburg, Germany, D-47055 | |
| Contact: Contact Person 49-211-811-7550 | |
| Universitaetsklinikum Essen | Recruiting |
| Essen, Germany, D-45122 | |
| Contact: Contact Person 49-201-723-2578 | |
| Alfried Krupp Krankenhaus | Recruiting |
| Essen, Germany, D-45117 | |
| Contact: Contact Person 49-201-434-2548 | |
| II Medizinische Klinik - Klinikum Fuerth | Recruiting |
| Fuerth, Germany, D-90766 | |
| Contact: Contact Person 49-911-976-1474 | |
| Evangelische Kliniken Gelsenkirchen GmbH | Recruiting |
| Gelsenkirchen, Germany, D-45879 | |
| Contact: Contact Person 49-209-160-1201 | |
| Wilhelm-Anton-Hospital gGmbH, Goch | Recruiting |
| Goch, Germany, D-47574 | |
| Contact: Contact Person 49-2823-891-105 | |
| Maria-Josef-Hospital Greven GmbH | Recruiting |
| Greven, Germany, D-48268 | |
| Contact: Contact Person 49-2571-502-203 | |
| Evangelisches Krankenhaus Hagen-Haspe GmbH | Recruiting |
| Hagen, Germany, D-58135 | |
| Contact: Contact Person 49-2331-476-3825 | |
| Allgemeines Krankenhaus Hagen | Recruiting |
| Hagen, Germany, D-58095 | |
| Contact: Contact Person 49-2331-201-2622 | |
| Henriettenstiftung Krankenhaus | Recruiting |
| Hannover, Germany, D-30171 | |
| Contact: Contact Person 49-511-289-3350 | |
| Praxisgemeinschaft fuer Gynaekologische Onkologie | Recruiting |
| Hildesheim, Germany, D-31134 | |
| Contact: Contact Person 49-5121-590-20 | |
| Universitaetsklinikum des Saarlandes | Recruiting |
| Homburg, Germany, D-66424 | |
| Contact: Contact Person 49-6841-162-8101 | |
| Klinikum Kaufbeuren Ostallgaeu | Recruiting |
| Kaufbeuren, Germany, D-87600 | |
| Contact: Contact Person 49-8341-421-001 | |
| Katholisches Klinikum Koblenz Marienhof | Recruiting |
| Koblenz, Germany, D-56073 | |
| Contact: Contact Person 49-261-496-3101 | |
| Frankenwald Klinik | Recruiting |
| Kronach, Germany, D-96317 | |
| Contact: Contact Person 49-9261-5977-10 | |
| Internistische Onkologische Praxis - Kronach | Recruiting |
| Kronach, Germany, D-96317 | |
| Contact: Contact Person 49-9261-624-8161 | |
| St. Marien Hospital - Luenen | Recruiting |
| Luenen, Germany, D-44534 | |
| Contact: Contact Person 49-2306-772-701 | |
| St. Vincenz und Elisabeth Hospital | Recruiting |
| Mainz, Germany, D-55131 | |
| Contact: Contact Person 49-6131-575-1400 | |
| Klinikum Memmingen | Recruiting |
| Memmingen, Germany, D-87700 | |
| Contact: Contact Person 49-8331-702-257 | |
| Klinikum Minden | Recruiting |
| Minden, Germany, D-32423 | |
| Contact: Contact Person 49-571-801-4101 | |
| Krankenhaus Bethanien | Recruiting |
| Moers, Germany, D-47441 | |
| Contact: Contact Person 49-2841-200-2600 | |
| Marienhaus Klinikum St. Elisabeth Neuwied | Recruiting |
| Neuwied, Germany, D-56564 | |
| Contact: Contact Person 49-2631-821-213 | |
| Evangelisches Krankenhaus Oberhausen | Recruiting |
| Oberhausen, Germany, D-46004 | |
| Contact: Contact Person 49-208-881-00 | |
| Internistische Gemeinschaftspraxis - Offenbach | Recruiting |
| Offenbach, Germany, D-63065 | |
| Contact: Contact Person 49-69-812-626 | |
| Praxis fuer Haematologie und Onkoligie | Recruiting |
| Rheine, Germany, D-48431 | |
| Contact: Contact Person 49-5971-914-142 | |
| Klinikum Suedstadt Rostock | Recruiting |
| Rostock, Germany, D-18059 | |
| Contact: Contact Person 49-381-4401-4590 | |
| Marienkrankenhaus Schwerte gem. GmbH | Recruiting |
| Schwerte, Germany, D-58239 | |
| Contact: Contact Person 49-2304-109-234 | |
| Staedtisches Klinikum Solingen | Recruiting |
| Solingen, Germany, D-42653 | |
| Contact: Contact Person 49-212-547-2371 | |
| Praxis Fuer Internistische Haematologie / Onkologie | Recruiting |
| Troisdorf, Germany, D-53840 | |
| Contact: Contact Person 49-2241-975-422 | |
| Katherinen-Hospital gGmbH | Recruiting |
| Unna, Germany, D-59423 | |
| Contact: Contact Person 49-2303-100-2842 | |
| Marien-Hospital Wesel gGmbH | Recruiting |
| Wesel, Germany, D-46483 | |
| Contact: Contact Person 49-281-104-1160 | |
| Marien-Hospital Witten | Recruiting |
| Witten, Germany, D-58452 | |
| Contact: Contact Person 49-2302-173-1328 | |
| Bethesda Krankenhaus Wuppertal gGmbH | Recruiting |
| Wuppertal, Germany, D-42109 | |
| Contact: Contact Person 49-202-290-2152 | |
| Haematologie / Onkologische Schwerpunktpraxis | Recruiting |
| Wuppertal, Germany, D-42275 | |
| Contact: Contact Person 49-202-254-1150 | |
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
| Study Chair: | Ulrike Nitz, PhD | Heinrich-Heine University, Duesseldorf |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00309920 History of Changes |
| Other Study ID Numbers: | CDR0000458037, WGSG-ARA-PLUS, AVENTIS-WGSG-ARA-PLUS, SANOFI-WGSF-ARA-PLUS, EU-205108 |
| Study First Received: | March 29, 2006 |
| Last Updated: | February 6, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage IIIA breast cancer stage IIIC breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Fluorouracil Docetaxel Doxorubicin Epirubicin Darbepoetin alfa Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Antimetabolites Antimetabolites, Antineoplastic Hematinics Hematologic Agents |
ClinicalTrials.gov processed this record on May 19, 2013