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Completed

NCT Number: NCT00668616

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Oskar-Ziethen-Krankenhaus

Berlin, State of Berlin, 10365, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide, Epirubicin, Paclitaxel

Drug

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

Epirubicin, Paclitaxel, Filgrastim

Drug

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 outcomes

  1. progression-free time

    Time frame: every 3-6 months

Secondary outcomes

  1. toxicity

  2. overall survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

North Eastern German Society of Gynaecological Oncology

Other

Registry information

Official study 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+)

Important dates

Study start
2000
Primary completion
2005
Study completion
2009
First posted
Apr 29, 2008
Registry last updated
Jul 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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