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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Cyclophosphamide, Epirubicin, Paclitaxel; Drug: Epirubicin, Paclitaxel, Filgrastim

• Study Type: Interventional
• Enrollment (Actual): 1034
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	every 3-6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	5 years
toxicity

Collaborators and Investigators

• Sponsor: North Eastern German Society of Gynaecological Oncology

Study record dates

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: breast cancer with 1-3 afflicted axillary lymph nodes
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Paclitaxel; Epirubicin; Albumin-Bound Paclitaxel
• Other Study ID Numbers: 170200