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Completed

NCT Number: NCT02855775

Monoclonal Antibodies Elimination in Breast Cancer Patient

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Régional Universitaire

Besançon, 25030, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

additional blood sample

Other

blood sample every 3 weeks

Primary outcomes

  1. clearance of the bevacizumab

    Time frame: 9 months

Secondary outcomes

  1. clearance of the trastuzumab

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: PK-MAB

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Aug 4, 2016
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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