Adjuvant Treatment of Breast Cancer With 1-3 Aflicted Lymph Nodes - Full Text View

Sponsored by:	North Eastern Germany Society of Gynaecologic Oncology
Information provided by:	North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:	NCT00668616

Purpose

The purpose of this study is to determine whether a treatment with 4 cycles anthracycline + cyclophoshamide followed by administration of 4 cycles paclitaxel is more effective than therapy with 4 cy<cles of anthracycline adminbistration followed by 4 cycles of paclitaxel

Condition	Intervention	Phase
Breast Cancer	Drug: Cyclophosphamide, Epirubicin, Paclitaxel Drug: Epirubicin, Paclitaxel, Filgrastim	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Filgrastim Paclitaxel Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Cyclophosphamid + Farmorubicin® With Subsequent Administration of Taxol® (q3w) Versus Intensified Administration of Farmorubicin® Followed by Taxol® (q2w) in the Adjuvant Treatment of Breast Cancer in Patients With 1-3 Afflicted Lymph Nodes (1-3 LK+)

Further study details as provided by North Eastern Germany Society of Gynaecologic Oncology:

Primary Outcome Measures:

progression-free time [ Time Frame: every 3-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

toxicity [ Designated as safety issue: Yes ]
overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment:	1034
Study Start Date:	March 2000
Estimated Study Completion Date:	July 2009
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Cyclophosphamide, Epirubicin, Paclitaxel 4 cycles of 600 mg/m² cyclophosphamide i.v. and 90 mg/m2 Farmorubicin i.v. on day 1, q21d followed by 4 cycles of 175 mg/m² Taxol, day 1, q21d
2: Experimental	Drug: Epirubicin, Paclitaxel, Filgrastim cycle 1-4: 120 mg/m² Epirubicin i.v. on day 1, q14d, 5 µg/kg s.c. filgrastim day 5-10 (if leucocytes are lower than 10000/µl) cycle 5-8: 175 mg/m² Paclitaxel i.v. on day 1, q14d, 5 µg/kg s.c. filgrastim day 5-10 (if leucocytes are lower than 10000/µl)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

women with histologically proven breast cancer (pT1/pT2/pT3, pN1, N0)
ECOG performance status 0-1
start of adjuvant therapy not later than 4 weeks after surgery
hematology: platelets at least 100xGpt/l, neutrophiles at least 2xGpt/l
normal liver function as defined by: bilirubine till 1.5 x normal value, SGOT/SGPT till 1.25 x normal value
normal kidney function as defined by: creatine till 1.5 x normal value
negative pregnancy test for patients before menopause and effective contraception
written informed consent

Exclusion Criteria:

prior radiation, chemotherapy, hormontherapy and immunotherapy
patients with more than 3 afflicted lymph nodes
afflicted lymph nodes on the cantralateal side and/or afflicted supraclavicular or intraclavicular lymph nodes
bilateral breast cancer or second carcinoma of the breast
inflammatory breast cancer and/or distant metastases
existing clinically relevant peripheral neuropathie
heart infection during the last 6 months or therapeutically not compensated heart failure or cardiac arrhythmias of at least LOWN II
patients with active infections and/or not controlled hypercalcemia
pregnant or breastfeeding women or women of child-bearing age who do not use effictive contrazeptiva

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668616

Locations

Germany
Oskar-Ziethen-Krankenhaus
Berlin, Germany, 10365

Sponsors and Collaborators

North Eastern Germany Society of Gynaecologic Oncology

More Information

Study ID Numbers:	170200
Study First Received:	April 25, 2008
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00668616
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by North Eastern Germany Society of Gynaecologic Oncology:

breast cancer with 1-3 afflicted axillary lymph nodes

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Breast Neoplasms

Cyclophosphamide
Epirubicin
Breast Diseases

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009