FATTAX: Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer

Sponsor

Centre Henri Becquerel (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05858398

Collaborator

Erasmus Medical Center (Other), Universitaire Ziekenhuizen KU Leuven (Other)

Enrollment

Location

Arm

35.1

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Biological: pharmacokinetics blood sample assessment	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Influence of Body Composition, Total Body Fat and Body Mass Index on the Pharmacokinetics of Docetaxel in Localized Breast Cancer

Anticipated Study Start Date :

May 30, 2023

Anticipated Primary Completion Date :

May 2, 2025

Anticipated Study Completion Date :

May 2, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pharmocokinetics blood sample assessment during first administration of docetaxel several pharmacokinetics samples will be assessed	Biological: pharmacokinetics blood sample assessment pharmacokinetics blood sample assessment during the first exposure to docetaxel

Arm

Intervention/Treatment

Experimental: Pharmocokinetics blood sample assessment

during first administration of docetaxel several pharmacokinetics samples will be assessed

Biological: pharmacokinetics blood sample assessment

pharmacokinetics blood sample assessment during the first exposure to docetaxel

Outcome Measures

Primary Outcome Measures

Comparison of docetaxel area under courb between obese and lean patients [8 hours after the end of first cycle of docetaxel]

Secondary Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Henri Becquerel	Rouen		France	76038

Sponsors and Collaborators

Centre Henri Becquerel
Erasmus Medical Center
Universitaire Ziekenhuizen KU Leuven

Investigators

Principal Investigator: Florian Clatot, Prof, Centre Henri Becquerel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Henri Becquerel

ClinicalTrials.gov Identifier:

NCT05858398

Other Study ID Numbers:

CHB22.03

First Posted:

May 15, 2023

Last Update Posted:

May 15, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Henri Becquerel

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of May 15, 2023