Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: pharmacokinetics blood sample assessment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Influence of Body Composition, Total Body Fat and Body Mass Index on the Pharmacokinetics of Docetaxel in Localized Breast Cancer
Overview
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
Detailed description
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).
Interventions
- Biological pharmacokinetics blood sample assessment
pharmacokinetics blood sample assessment during the first exposure to docetaxel
Primary outcome measures
- Comparison of docetaxel area under courb between obese and lean patients [Time frame: 8 hours after the end of first cycle of docetaxel]
Secondary outcome measures (4)
- Comparison of docetaxel area under courb between overweight and lean patients [Time frame: 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) [Time frame: 8 hours after the end of first cycle of docetaxel]
- Interrelationship of docetaxel area under courb and docetaxel induced side effects [Time frame: 3 months after first cycle of docetaxel]
- Interrelationship between of body composition and leptine/adiponectine rates [Time frame: 8 hours after the end of first cycle of docetaxel]
Eligibility criteria
Inclusion criteria
- Woman older than
- Early breast cancer
- CT-scan of less than 3 months, including L3 level
- Indication of docetaxel at 100 mg/m² as adjuvant CT
Exclusion criteria
- HER2 amplified or triple negative tumors
- Pregnant or breastfeeding women
- Patients under guardianship or curatorship
- Concomitant administration of another cytotoxic drug or targeted therapy
- Psychosocial disorder
- Administration of another cytotoxic drug or targeted therapy within 20 days prior to blood collection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Centre Henri Becquerel — Rouen
Identifiers
NCT: NCT05858398 · CHB22.03