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| Name | Class |
|---|---|
| Erasmus Medical Center | OTHER |
| Universitaire Ziekenhuizen KU Leuven | OTHER |
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The purpose of this study is to determine if pharmacokinetics of docetaxel is modified by the body composition (assessed by the BMI but also by CT-scan) in patients treated by docetaxel as adjuvant treatment of a localized breast cancer
Half of the patients treated for a localized breast cancer are obese or overweighted. Recently published post-hoc analyses of a large randomised trial (BIG-2-98) revealed that BMI could impact the benefit of a docetaxel based chemotherapy, but not of an anthracyclin based chemotherapy.
One of the hypothesis is that the distribution volume of hydrophobic drugs, such as docetaxel, may be influenced by the BMI, and more precisely by the amount of total fat.
In that context, we aim to assess the docetaxel pharmacokinetics during its first exposure for localized breast cancer, and compare these results according to 3 groups of patients (lean, overweight and obese).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmocokinetics blood sample assessment | Experimental | during first administration of docetaxel several pharmacokinetics samples will be assessed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmacokinetics blood sample assessment | Biological | pharmacokinetics blood sample assessment during the first exposure to docetaxel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of docetaxel area under courb between obese and lean patients | 8 hours after the end of first cycle of docetaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of docetaxel area under courb between overweight and lean patients | 8 hours after the end of first cycle of docetaxel | |
| Comparison of docetaxel area under courb according to BMI versus body composition (assessed by CT scan) | 8 hours after the end of first cycle of docetaxel |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florian Clatot, Prof | Contact | +33232082231 | florian.clatot@chb.unicancer.fr | |
| Doriane Richard, PhD | Contact | +33232082985 | doriane.richard@chb.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Florian Clatot, Prof | Centre Henri Becquerel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Henri Becquerel | Recruiting | Rouen | 76038 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Interrelationship of docetaxel area under courb and docetaxel induced side effects | 3 months after first cycle of docetaxel |
| Interrelationship between of body composition and leptine/adiponectine rates | 8 hours after the end of first cycle of docetaxel |
| D017437 |
| Skin and Connective Tissue Diseases |