Monoclonal Antibodies Elimination in Breast Cancer Patient

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: additional blood sample

• Registration Number: NCT02855775
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

This Study evaluates covariables being able to potentially influence the elimination of the monoclonal antibodies (trastuzumab, bevacizumab and denosumab).

Detailed Description

Monoclonal antibodies are very widely used in cancer treatment . Certain patients benefit from these antibodies for several years and it is conceivable to wonder about the evolution of the pharmacokinetics of these antibodies.

Study Timeline

• Study Start: 2013-09-25
• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-04
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-15
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• A diagnosed cancer
• patient treated by bevacizumab or trastuzumab
• Life expectancy of at least 3 months
• For the women: menopausal women for at least 24 months, sterilized surgically, or, for the women old enough to procreate, use a method of effective contraception (oral contraceptives, contraceptive injections, intra-uterine devices, method of the double barrier, the contraceptive patches). This contraception will have to be pursued during 6 months after the end of the treatment by bevacizumab or by trastuzumab.

Exclusion Criteria

• For Patients treated by trastuzumab: Dyspnoea of severe rest in touch with complications due to the disease or requiring an oxygen therapy.
• Hypocalcemia severe untreated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trastuzumab	additional blood sample	Trastuzumab in monotherapy or in association to other anticancer agents pharmacokinetic assessment with blood sample with additional blood sample
Bevacizumab	additional blood sample	Bevacizumab in monotherapy or in association to other anticancer agents pharmacokinetic assessment with blood sample with additional blood sample

Primary Outcome Measures

Name	Time	Method
clearance of the bevacizumab	9 months

Secondary Outcome Measures

Name	Time	Method
clearance of the trastuzumab	9 months

Trial Locations

Locations (1)

Centre Hospitalier Régional Universitaire; 🇫🇷 Besançon, France