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

NCT00668616 | Completed Phase 3

• 1 other identifier: 170200
• Study Type: interventional
• Target: 1,034
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

breast cancer with 1-3 afflicted axillary lymph nodes

Outcome Measures

Primary Outcomes (1)

• progression-free time

  every 3-6 months

Secondary Outcomes (2)

• toxicity

• overall survival

  5 years

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Cyclophosphamide, Epirubicin, Paclitaxel

2

EXPERIMENTAL

Drug: Epirubicin, Paclitaxel, Filgrastim

Interventions

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

1

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)

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• North Eastern German Society of Gynaecological Oncology: lead

Study Sites (1)

Oskar-Ziethen-Krankenhaus

Berlin, State of Berlin, 10365, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Epirubicin; Paclitaxel; Filgrastim

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 25, 2008
• First Posted: April 29, 2008
• Study Start: March 1, 2000
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2009
• Last Updated: July 29, 2010

Record last verified: 2010-07

Locations

DE (1)