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

This study has been completed.

Sponsor:

Information provided by:

North Eastern Germany Society of Gynaecologic Oncology

ClinicalTrials.gov Identifier:

NCT00668616

First received: April 25, 2008

Last updated: July 28, 2010

Last verified: July 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	April 25, 2008
Last Updated Date	July 28, 2010
Start Date ^ICMJE	March 2000
Primary Completion Date	July 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 28, 2008)	progression-free time [ Time Frame: every 3-6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00668616 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 28, 2008)	toxicity [ Designated as safety issue: Yes ] overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Adjuvant Treatment of Breast Cancer With 1-3 Aflicted Lymph Nodes
Official Title ^ICMJE	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+)
Brief Summary	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
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Breast Cancer
Intervention ^ICMJE	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 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)
Study Arm (s)	Active Comparator: 1 Intervention: Drug: Cyclophosphamide, Epirubicin, Paclitaxel Experimental: 2 Intervention: Drug: Epirubicin, Paclitaxel, Filgrastim
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1034
Completion Date	July 2009
Primary Completion Date	July 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT00668616
Other Study ID Numbers ^ICMJE	170200
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	North Eastern Germany Society of Gynaecologic Oncology
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	North Eastern Germany Society of Gynaecologic Oncology
Verification Date	July 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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