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Monoclonal Antibodies Elimination in Breast Cancer Patient

Study of the Relative Impact of the Neonatal Fc Receptor (FcRn) and the Therapeutic History on Monoclonal Antibodies Elimination. Proof of the Concept on Patients Treated by Bevacizumab or Trastuzumab in Breast Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02855775
Acronym
PK-MAB
Enrollment
76
Registered
2016-08-04
Start date
2013-09-25
Completion date
2020-10-15
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

blood sample every 3 weeks

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
clearance of the bevacizumab9 months

Secondary

MeasureTime frame
clearance of the trastuzumab9 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026