Breast CancerNCT00309920
Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer
A study testing darbepoetin alfa, cyclophosphamide and docetaxel in people with Breast Cancer, run by Heinrich-Heine University, Duesseldorf at 47 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- darbepoetin alfa, cyclophosphamide and docetaxel
- How many people
- 1,234 participants
- Where
- 47 sitesGermany
- Study dates
- Jan 2004to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Germany47 sites, 47 recruiting
- Recruiting
Kreiskrankenhaus Aurich
Aurich, D-26603
Contact Person, 49-41-94-1802
- Recruiting
Maria-Hilf-Krankenhaus
Bergheim, D-50126
Contact Person, 49-2271-87-0
- Recruiting
Evangelisches Krankenhaus - Bergisch Gladbach
Bergisch, D-51465
Contact Person, 49-2202-122-497
- Recruiting
Johanniter-Krankenhaus Bonn
Bonn, D-53113
Contact Person, 49-228-543-2401
- Recruiting
Onkologische Gemeinschaftspraxis
Bonn, D-53119
Contact Person, 49-228-908-1900
- Recruiting
Praxis fuer Haematologie - Onkologie
Bonn-Duisdorf, D-53123
Contact Person, 49-228-644-546
- Recruiting
St. Rochus Hospital
Castrop-Rauxel, D-44575
Contact Person, 49-2305-294-250
- Recruiting
Praxis Fuer Haematologie Internistische Onkologie
Cologne, D-50677
Contact Person, 49-221-931-8220
- Recruiting
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, D-50924
Contact Person, 49-221-478-4940
- Recruiting
St. Elisabeth-Krankenhaus - Koeln
Cologne, D-50935
Contact Person, 49-221-4677-0-521
- Recruiting
Klinikum Deggendorf
Deggendorf, D-94469
Contact Person, 49-991-380-3172
- Recruiting
Onkologische Schwerpunktpraxis
Duisburg, D-47055
Contact Person, 49-211-811-7550
- Recruiting
Universitaetsklinikum Duesseldorf
Düsseldorf, D-40225
Contact Person, 49-211-811-7550
- Recruiting
Alfried Krupp Krankenhaus
Essen, D-45117
Contact Person, 49-201-434-2548
- Recruiting
Universitaetsklinikum Essen
Essen, D-45122
Contact Person, 49-201-723-2578
- Recruiting
II Medizinische Klinik - Klinikum Fuerth
Fürth, D-90766
Contact Person, 49-911-976-1474
- Recruiting
Evangelische Kliniken Gelsenkirchen GmbH
Gelsenkirchen, D-45879
Contact Person, 49-209-160-1201
- Recruiting
Wilhelm-Anton-Hospital gGmbH, Goch
Goch, D-47574
Contact Person, 49-2823-891-105
- Recruiting
Maria-Josef-Hospital Greven GmbH
Greven, D-48268
Contact Person, 49-2571-502-203
- Recruiting
Allgemeines Krankenhaus Hagen
Hagen, D-58095
Contact Person, 49-2331-201-2622
- Recruiting
Evangelisches Krankenhaus Hagen-Haspe GmbH
Hagen, D-58135
Contact Person, 49-2331-476-3825
- Recruiting
Henriettenstiftung Krankenhaus
Hanover, D-30171
Contact Person, 49-511-289-3350
- Recruiting
Praxisgemeinschaft fuer Gynaekologische Onkologie
Hildesheim, D-31134
Contact Person, 49-5121-590-20
- Recruiting
Universitaetsklinikum des Saarlandes
Homburg, D-66424
Contact Person, 49-6841-162-8101
- Recruiting
Klinikum Kaufbeuren Ostallgaeu
Kaufbeuren, D-87600
Contact Person, 49-8341-421-001
- Recruiting
Katholisches Klinikum Koblenz Marienhof
Koblenz, D-56073
Contact Person, 49-261-496-3101
- Recruiting
Frankenwald Klinik
Kronach, D-96317
Contact Person, 49-9261-5977-10
- Recruiting
Internistische Onkologische Praxis - Kronach
Kronach, D-96317
Contact Person, 49-9261-624-8161
- Recruiting
Knappschaft Krankenhaus
Langendreer, D-44892
Contact Person, 49-234-299-3300
- Recruiting
St. Marien Hospital - Luenen
Lünen, D-44534
Contact Person, 49-2306-772-701
- Recruiting
St. Vincenz und Elisabeth Hospital
Mainz, D-55131
Contact Person, 49-6131-575-1400
- Recruiting
Klinikum Memmingen
Memmingen, D-87700
Contact Person, 49-8331-702-257
- Recruiting
Klinikum Minden
Minden, D-32423
Contact Person, 49-571-801-4101
- Recruiting
Krankenhaus Bethanien
Moers, D-47441
Contact Person, 49-2841-200-2600
- Recruiting
Marienhaus Klinikum St. Elisabeth Neuwied
Neuwied, D-56564
Contact Person, 49-2631-821-213
- Recruiting
Evangelisches Krankenhaus Oberhausen
Oberhausen, D-46004
Contact Person, 49-208-881-00
- Recruiting
Internistische Gemeinschaftspraxis - Offenbach
Offenbach, D-63065
Contact Person, 49-69-812-626
- Recruiting
Praxis fuer Haematologie und Onkoligie
Rheine, D-48431
Contact Person, 49-5971-914-142
- Recruiting
Klinikum Suedstadt Rostock
Rostock, D-18059
Contact Person, 49-381-4401-4590
- Recruiting
Marienkrankenhaus Schwerte gem. GmbH
Schwerte, D-58239
Contact Person, 49-2304-109-234
- Recruiting
Staedtisches Klinikum Solingen
Solingen, D-42653
Contact Person, 49-212-547-2371
- Recruiting
Praxis Fuer Internistische Haematologie / Onkologie
Troisdorf, D-53840
Contact Person, 49-2241-975-422
- Recruiting
Katherinen-Hospital gGmbH
Unna, D-59423
Contact Person, 49-2303-100-2842
- Recruiting
Marien-Hospital Wesel gGmbH
Wesel, D-46483
Contact Person, 49-281-104-1160
- Recruiting
Marien-Hospital Witten
Witten, D-58452
Contact Person, 49-2302-173-1328
- Recruiting
Bethesda Krankenhaus Wuppertal gGmbH
Wuppertal, D-42109
Contact Person, 49-202-290-2152
- Recruiting
Haematologie / Onkologische Schwerpunktpraxis
Wuppertal, D-42275
Contact Person, 49-202-254-1150
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- darbepoetin alfa, cyclophosphamide, docetaxel, doxorubicin hydrochloride, epirubicin hydrochloride
- Keywords
- stage IIIA breast cancer, stage IIIC breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darbepoetin alfaBiological
cyclophosphamideDrug
docetaxelDrug
epirubicin hydrochlorideDrug
fluorouracilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival at 6 months to 5 years after treatment
Secondary outcomes (4)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 1,234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Investigators
- Ulrike Nitz, PhD, Study chair, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309920
- Sponsor's protocol ID
- CDR0000458037
- Other IDs
- WGSG-ARA-PLUS, AVENTIS-WGSG-ARA-PLUS, SANOFI-WGSF-ARA-PLUS, EU-205108
- Status last verified
- Apr 2006
- First submitted
- 29 Mar 2006
- Last updated
- 9 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Therapy of Breast Cancer: Impact of Erythropoiesis Stimulating Factors on Event Free Survival High Risk Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT00309920
- Acronym / sponsor ID
- CDR0000458037
- Conditions
- Breast Cancer
- Keywords
- stage IIIA breast cancer, stage IIIC breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,234 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Jan 2004
- First posted
- 3 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| darbepoetin alfa | Biological | – |
| cyclophosphamide | Drug | – |
| docetaxel | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| epirubicin hydrochloride | Drug | – |
| fluorouracil | Drug | – |
Primary outcome
Disease-free survival at 6 months to 5 years after treatment
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrike Nitz, PhD study chair
Heinrich-Heine University, Duesseldorf
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing darbepoetin alfa, cyclophosphamide and docetaxel in people with Breast Cancer, run by Heinrich-Heine University, Duesseldorf at 47 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival at 6 months to 5 years after treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2009.