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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00668616
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : July 29, 2010
Information provided by:
North Eastern Germany Society of Gynaecologic Oncology

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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Cyclophosphamide, Epirubicin, Paclitaxel Drug: Epirubicin, Paclitaxel, Filgrastim Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1034 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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+)
Study Start Date : March 2000
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 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
Experimental: 2 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)

Primary Outcome Measures :
  1. progression-free time [ Time Frame: every 3-6 months ]

Secondary Outcome Measures :
  1. toxicity
  2. overall survival [ Time Frame: 5 years ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00668616

Berlin, Germany, 10365
Sponsors and Collaborators
North Eastern Germany Society of Gynaecologic Oncology Identifier: NCT00668616     History of Changes
Other Study ID Numbers: 170200
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: July 29, 2010
Last Verified: July 2010

Keywords provided by North Eastern Germany Society of Gynaecologic Oncology:
breast cancer with 1-3 afflicted axillary lymph nodes

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Adjuvants, Immunologic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors