Docetaxel in Treating Older Women With Metastatic Breast Cancer

Phase 2

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT00104624
• Lead Sponsor: UNICANCER

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well docetaxel works in treating older women with metastatic breast cancer and whether it helps improve the ability to perform daily activities.

Detailed Description

OBJECTIVES:

Primary

* Determine degree of autonomy in instrumental activities of daily living on-therapy and at 6 and 12 months, as measured by Lawton's Instrumental Activities of Daily Living Scale, in older women with metastatic adenocarcinoma of the breast treated with docetaxel.

Secondary

* Determine the response rate in patients treated with this drug.

* Determine overall and progression-free survival of patients treated with this drug.

* Determine the degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale, in patients treated with this drug.

* Determine mood status, as measured by the Geriatric Depression Scale, of patients treated with this drug.

* Determine toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV on days 1 and 15. Treatment repeats every 28 days for 6 courses.

Ability to perform daily activities is assessed periodically.

PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.

Study Timeline

• Study First Submitted: 2005-03-03
• Study First Submitted QC: 2005-03-03
• Study First Posted: 2005-03-04
• Study Start: 2005-05
• Primary Completion: 2007-07
• Study Completion: 2008-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-02
• Last Update Posted: 2013-09-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 53

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of autonomy in instrumental activities of daily living as measured by Lawton's Instrumental Activities of Daily Living Scale during therapy and at 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Overall survival
Response rate
Degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale
Progression-free survival
Mood status as measured by the Geriatric Depression Scale
Toxicity

Trial Locations

Locations (7)

Centre Henri Becquerel; 🇫🇷 Rouen, France

Clinique De Genolier; 🇨🇭 Genolier, Switzerland

C.H. Senlis; 🇫🇷 Senlis, France

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes; 🇫🇷 Marseille, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Institut Curie Hopital; 🇫🇷 Paris, France

Istituto Nazionale Di Riposo e Cura per Anziani; 🇮🇹 Rome, Italy