PK-MAB: Monoclonal Antibodies Elimination in Breast Cancer Patient

• Sponsor: Centre Hospitalier Universitaire de Besancon (Other)
• Overall Status: Completed
• CT.gov ID: NCT02855775
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Arms: 2
• Actual Duration (Months): 84.7
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: additional blood sample	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Sep 25, 2013
• Actual Primary Completion Date: Oct 15, 2020
• Actual Study Completion Date: Oct 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bevacizumab Bevacizumab in monotherapy or in association to other anticancer agents pharmacokinetic assessment with blood sample with additional blood sample	Other: additional blood sample; blood sample every 3 weeks
Experimental: Trastuzumab Trastuzumab in monotherapy or in association to other anticancer agents pharmacokinetic assessment with blood sample with additional blood sample	Other: additional blood sample; blood sample every 3 weeks

Outcome Measures

Primary Outcome Measures

1. clearance of the bevacizumab [9 months]

Secondary Outcome Measures

1. clearance of the trastuzumab [9 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Régional Universitaire	Besançon		France	25030

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Besancon
• ClinicalTrials.gov Identifier: NCT02855775
• Other Study ID Numbers: API/2011/21
• First Posted: Aug 4, 2016
• Last Update Posted: Apr 19, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Apr 19, 2021