Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Pegylated liposomal doxorubicin; Drug: Docetaxel

• Registration Number: NCT00524810
• Lead Sponsor: ARCAGY/ GINECO GROUP

Brief Summary

Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer

Detailed Description

Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer. Patients will receive pyridoxin to prevent cutaneo-mucinous toxicities.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2007-09-03
• Study First Submitted QC: 2007-09-04
• Study First Posted: 2007-09-05
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-29
• Last Update Posted: 2011-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

Inclusion Criteria

• first metastatic chemo line
• presence of measurable or bone lesion
• at least one lesion outside the radiated areas
• can have previously received hormonotherapy, chemotherapy in adjuvant phase, radiotherapy if older than 4 weeks

Exclusion Criteria

• only local tumoral progression
• symptomatic cerebral metastasis
• neuropathy > NCI-CTC 2
• previous cancer within 10 years _ previous cancer within 10 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Caelyx - Taxotere	Pegylated liposomal doxorubicin	-
Caelyx - Taxotere	Docetaxel	-

Primary Outcome Measures

Name	Time	Method
Non-progression rate after 6 cycles	6 months

Secondary Outcome Measures

Name	Time	Method
tolerance and toxicity	6 months
Time to Progression	5 years
Tumor response and duration	5 years
Overall survival	5 years

Trial Locations

Locations (1)

Hôpital HOTEL DIEU; 🇫🇷 Paris, France