RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of docetaxel or paclitaxel in treating women who have unresectable locally advanced or metastatic breast cancer.

Condition	Treatment or Intervention	Phase
stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage IIIB breast cancer	Drug: docetaxel  Drug: paclitaxel  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES:

• Compare the response rate, progression free survival, and overall survival in women with unresectable locally advanced or metastatic breast cancer treated with two different schedules of docetaxel or paclitaxel.
• Compare the toxicities and pharmacoeconomics of these four regimens in these patients.
• Compare the quality of life of patients treated with these four regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, age, ECOG performance status, hormone receptor status (positive vs negative), metastasis to liver (yes vs no), and presence of disease progression following anthracyclines (yes vs no).

Patients are randomized to one of four treatment arms.

• Arm I: Patients receive docetaxel IV over 1 hour on day 1.
• Arm II: Patients receive paclitaxel IV over 3 hours on day 1.
• Arm III: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36.
• Arm IV: Patients receive paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Courses repeat every 3 weeks (arms I and II) or every 8 weeks (arms III and IV) in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed prior to treatment and then every 8 weeks.

PROJECTED ACCRUAL: A total of 165 patients will be accrued for this study.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven unresectable locally advanced or metastatic breast cancer
• Refractory or relapsed disease after neoadjuvant or adjuvant anthracyclines
• At least one bidimensionally measurable lesion
• No brain metastasis
• No bone metastases, lymphangitis carcinomatous, ascites, or pleural effusion as sole site of metastatic disease
• Hormone receptor status:
• Known hormone receptor status

PATIENT CHARACTERISTICS: Age:

• 18 to 75

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2 OR
• Karnofsky 60-100%

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• AST and ALT no greater than 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2.5 times ULN
• Bilirubin normal

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No uncontrolled angina or arrhythmia
• No myocardial infarction within the past 6 months
• No New York Heart Association class III or IV heart disease

Other:

• No sensitive neuropathy worse than grade 2
• No other significant, uncontrolled medical or psychiatric condition
• No serious active infection
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other prior malignancy except treated nonmelanomatous skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy:

• At least 4 weeks since prior specific antitumoral immunotherapy

Chemotherapy:

• See Disease Characteristics
• No prior taxanes
• At least 4 weeks since other prior specific antitumoral chemotherapy

Endocrine therapy:

• At least 4 weeks since prior specific antitumoral hormonal therapy

Radiotherapy:

• At least 4 weeks since prior specific antitumoral radiotherapy

Surgery:

• Not specified

Other:

• No other concurrent experimental medication

France
      American Hospital of Paris, Neuilly-sur-Seine,  F-92202,  France
      C.H. Senlis, Senlis,  60309,  France
      C.H.G. Beauvais, Beauvais,  60021,  France
      Centre de Radiotherapie et Oncologie Saint-Faron, Mareuil-les-Meaux,  77100,  France
      Centre D'Oncologie Du Pays-Basque, Bayonne,  F-64100,  France
      Centre du Rouget, Sarcelles,  95250,  France
      Centre Hospitalier d'Antibes, Antibes,  06606,  France
      Centre Hospitalier de Mulhouse, Mulhouse,  68051,  France
      Centre Hospitalier Laennec, Creil,  60109,  France
      Centre Hospitalier Victor Dupouy, Argenteuil,  95107,  France
      Centre Jean Bernard, Le Mans,  72000,  France
      Centre Jean Perrin, Clermont-Ferrand,  63011,  France
      CH Meulan, Meulan,  78250,  France
      Clinique de l'Orangerie, Strasbourg,  67010,  France
      Clinique Fleming, Tours,  37000,  France
      Clinique Floreal, Bagnolet,  28630,  France
      Clinique Geoffroy St. Hillaire, Paris,  75005,  France
      Clinique Hartmann, Neuilly-sur-Seine,  92200,  France
      Clinique Pasteur, Toulouse,  31076,  France
      Clinique Ste - Marie, Pontoise,  95301,  France
      Hopital Desgenettes - Service de Medecine Interne, Lyon,  69998,  France
      Hopital Drevon, Dijon,  21000,  France
      Hopital Fontenoy, Chartres,  28018,  France
      Hopital Intercommunal De Creteil, Creteil,  94010,  France
      Hopital Louis Mourier, Colombes,  France
      Hopital Notre-Dame de Bon Secours, Metz,  57038,  France
      Hopital Saint Antoine, Paris,  75571,  France
      Hopital Saint Joseph, Marseille,  13008,  France
      Hopital Tenon, Paris,  75970,  France
      Hotel Dieu de Paris, Paris,  75181,  France
      Institut Sainte Catherine, Avignon,  84082,  France
      Intercommunal Hospital, Montfermeil,  93370,  France
      Polyclinique De Courlancy, Reims,  F-51100,  France
      Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie, Gien,  45500,  France
Luxembourg
      Hopital de la Ville D'Esch-sur-Alzette, Esch-sur-Alzette,  L-4005,  Luxembourg

Study chairs or principal investigators

Joseph Gligorov, MD,  Study Chair,  Hopital Tenon   

Study ID Numbers:  CDR0000068134; FRE-GERCOR-TAXMAX-SOO-1; EU-20029
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  August 3, 2000
ClinicalTrials.gov Identifier:  NCT00006120
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08