NCT02855775

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

7.1 years

First QC Date

July 28, 2016

Last Update Submit

April 15, 2021

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • clearance of the bevacizumab

    9 months

Secondary Outcomes (1)

  • clearance of the trastuzumab

    9 months

Study Arms (2)

Bevacizumab

EXPERIMENTAL

Bevacizumab in monotherapy or in association to other anticancer agents pharmacokinetic assessment with blood sample with additional blood sample

Other: additional blood sample

Trastuzumab

EXPERIMENTAL

Trastuzumab in monotherapy or in association to other anticancer agents pharmacokinetic assessment with blood sample with additional blood sample

Other: additional blood sample

Interventions

additional blood sampleOTHER

blood sample every 3 weeks

BevacizumabTrastuzumab

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Régional Universitaire

Besançon, 25030, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 4, 2016

Study Start

September 25, 2013

Primary Completion

October 15, 2020

Study Completion

October 15, 2020

Last Updated

April 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)