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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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+)

Resource links provided by NLM:


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
Study Completion Date: July 2009
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00668616     History of Changes
Other Study ID Numbers: 170200
Study First Received: April 25, 2008
Last Updated: July 28, 2010
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

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

ClinicalTrials.gov processed this record on September 14, 2014