Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer
Phase 2
Completed
- Conditions
- Metastatic Breast Cancer
- Interventions
- 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.
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
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Exclusion Criteria
- only local tumoral progression
- symptomatic cerebral metastasis
- neuropathy > NCI-CTC 2
- previous cancer within 10 years _ previous cancer within 10 years
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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