Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer

Phase 2

• Conditions: Breast Cancer

• Registration Number: NCT00006120
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2000-05
• Study First Submitted: 2000-08-03
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2006-03
• Last Update Submitted: 2008-07-23
• Last Update Posted: 2008-07-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (35)

Centre Hospitalier d'Antibes; 🇫🇷 Antibes, France

Centre Hospitalier Victor Dupouy; 🇫🇷 Argenteuil, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

Clinique Floreal; 🇫🇷 Bagnolet, France

Centre D'Oncologie Du Pays-Basque; 🇫🇷 Bayonne, France

C.H.G. Beauvais; 🇫🇷 Beauvais, France

Hopital Fontenoy; 🇫🇷 Chartres, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Hopital Louis Mourier; 🇫🇷 Colombes, France

Centre Hospitalier Laennec; 🇫🇷 Creil, France

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