Breast CancerFATTAXNCT05858398
Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer
A study testing pharmacokinetics blood sample assessment in people with Breast Cancer, run by Centre Henri Becquerel at 1 site in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- pharmacokinetics blood sample assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2023to 2 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Henri Becquerel
Rouen, 76038
Florian Clatot, Prof, +33232082231, florian.clatot@chb.unicancer.fr
Doriane Richard, PhD, +33232082985, doriane.richard@chb.unicancer.fr
About this study
Official title: Influence of Body Composition, Total Body Fat and Body Mass Index on the Pharmacokinetics of Docetaxel in Localized Breast Cancer
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
Read the 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).
- Conditions
- Breast Cancer
- Being tested
- pharmacokinetics blood sample assessment
- Keywords
- breast cancer, body composition, docetaxel, pharmacokinetics
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacokinetics blood sample assessmentBiological
pharmacokinetics blood sample assessment during the first exposure to docetaxel
| Study group | Role | What they receive |
|---|---|---|
| Pharmocokinetics blood sample assessment | Experimental | during first administration of docetaxel several pharmacokinetics samples will be assessed Receives: Biological: pharmacokinetics blood sample assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of docetaxel area under courb between obese and lean patients
Measured: 8 hours after the end of first cycle of docetaxel
Secondary outcomes (4)
Comparison of docetaxel area under courb between overweight and lean patients
Measured: 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)
Measured: 8 hours after the end of first cycle of docetaxel
Interrelationship of docetaxel area under courb and docetaxel induced side effects
Measured: 3 months after first cycle of docetaxel
Interrelationship between of body composition and leptine/adiponectine rates
Measured: 8 hours after the end of first cycle of docetaxel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start25 Oct 2023
- Primary completion2 May 2026 (estimated)
- Study completion2 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Sponsor
- Investigators
- Florian Clatot, Prof, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858398
- Sponsor's protocol ID
- CHB22.03
- Acronym
- FATTAX
- Status last verified
- Dec 2025
- First submitted
- 14 Apr 2023
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Body Composition, Total Body Fat and Body Mass Index on the Pharmacokinetics of Docetaxel in Localized Breast Cancer
- ClinicalTrials.gov ID
- NCT05858398
- Acronym / sponsor ID
- FATTAX / CHB22.03
- Conditions
- Breast Cancer
- Keywords
- breast cancer, body composition, docetaxel, pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, Universitaire Ziekenhuizen KU Leuven
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 2 May 2026 (estimated)
- Study completion
- 2 May 2027 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmocokinetics blood sample assessment | Experimental | Biological: pharmacokinetics blood sample assessmentduring first administration of docetaxel several pharmacokinetics samples will be assessed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmacokinetics blood sample assessmentpharmacokinetics blood sample assessment during the first exposure to docetaxel | Biological | Pharmocokinetics blood sample assessment |
Primary outcome
Comparison of docetaxel area under courb between obese and lean patients
Time frame: 8 hours after the end of first cycle of docetaxel
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florian Clatot, Prof principal investigator
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacokinetics blood sample assessment in people with Breast Cancer, run by Centre Henri Becquerel at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian Clatot, Prof (+33232082231, florian.clatot@chb.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of docetaxel area under courb between obese and lean patients (time frame: 8 hours after the end of first cycle of docetaxel). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.