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Monoclonal Antibodies Elimination in Breast Cancer Patient (PK-MAB)

C

Centre Hospitalier Universitaire de Besancon

Status

Completed

Conditions

Breast Cancer

Treatments

Other: additional blood sample

Study type

Interventional

Funder types

Other

Identifiers

NCT02855775
API/2011/21

Details and patient eligibility

About

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

Full 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.

Enrollment

76 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

76 participants in 2 patient groups

Bevacizumab
Experimental group
Description:
Bevacizumab in monotherapy or in association to other anticancer agents pharmacokinetic assessment with blood sample with additional blood sample
Treatment:
Other: additional blood sample
Trastuzumab
Experimental group
Description:
Trastuzumab in monotherapy or in association to other anticancer agents pharmacokinetic assessment with blood sample with additional blood sample
Treatment:
Other: additional blood sample

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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