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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

April 25, 2008
July 28, 2010
March 2000
July 2005   (final data collection date for primary outcome measure)
progression-free time [ Time Frame: every 3-6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00668616 on ClinicalTrials.gov Archive Site
  • toxicity [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Adjuvant Treatment of Breast Cancer With 1-3 Aflicted Lymph Nodes
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+)

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • 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)
  • Active Comparator: 1
    Intervention: Drug: Cyclophosphamide, Epirubicin, Paclitaxel
  • Experimental: 2
    Intervention: Drug: Epirubicin, Paclitaxel, Filgrastim
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1034
July 2009
July 2005   (final data collection date for primary outcome measure)

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
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00668616
170200
Not Provided
Not Provided
North Eastern Germany Society of Gynaecologic Oncology
Not Provided
Not Provided
North Eastern Germany Society of Gynaecologic Oncology
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP