Monoclonal Antibodies Elimination in Breast Cancer Patient

Breast Cancer Clinical Trial

— PK-MAB  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855775
• Other study ID #: API/2011/21
• Status: Completed
• Phase: N/A
• Start date: September 25, 2013
• Est. completion date: October 15, 2020

Study information

• Verified date: April 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• additional blood sample
blood sample every 3 weeks

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clearance of the bevacizumab		9 months
Secondary	clearance of the trastuzumab		9 months