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

July 28, 2010 updated by: North Eastern German Society of Gynaecological Oncology

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1034

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10365
        • Oskar-Ziethen-Krankenhaus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free time
Time Frame: every 3-6 months
every 3-6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 5 years
5 years
toxicity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Eastern German Society of Gynaecological Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

April 25, 2008

First Submitted That Met QC Criteria

April 28, 2008

First Posted (Estimate)

April 29, 2008

Study Record Updates

Last Update Posted (Estimate)

July 29, 2010

Last Update Submitted That Met QC Criteria

July 28, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 170200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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