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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00524810 |
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Date of registration:
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03/09/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer
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Scientific title:
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A Multi-center Phase II Study Evaluating the Efficacy and Tolerance of the Association of Liposomal Doxorubicin and Docetaxel in First Line Chemotherapy in Patients With Metastatic Breast Cancer |
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Date of first enrolment:
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February 2004 |
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Target sample size:
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67 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00524810 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Laure CHAUVENET, MD, PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hôpital HOTEL DIEU - Paris |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Metastatic Breast Cancer
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Intervention(s)
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Drug: Docetaxel
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Drug: Pegylated liposomal doxorubicin
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Primary Outcome(s)
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Non-progression rate after 6 cycles
[Time Frame: 6 months]
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Secondary Outcome(s)
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Tumor response and duration
[Time Frame: 5 years]
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Time to Progression
[Time Frame: 5 years]
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Overall survival
[Time Frame: 5 years]
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tolerance and toxicity
[Time Frame: 6 months]
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Secondary ID(s)
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CAPYTTOLE
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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