NCT02854618

Brief Summary

This study evaluates the immune response for patients affected by metastatic breast cancer treated by everolimus

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

November 26, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

6.4 years

First QC Date

August 1, 2016

Last Update Submit

January 29, 2021

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • level of the spontaneous anti-telomerase response

    evaluation by Enzyme-Linked Immunospot (ELIspot) and by Enzyme-Linked Immunosorbent Assay (ELISA test)

    12 months

Secondary Outcomes (8)

  • T lymphocytes level

    12 months

  • everolimus level in serum patients

    12 months

  • angiopoietin 2 level

    12 months

  • CD138 level

    12 months

  • ps6K expression

    12 months

  • +3 more secondary outcomes

Study Arms (1)

Everolimus treatment

EXPERIMENTAL
Other: additional blood sample

Interventions

additional blood sampleOTHER
Everolimus treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients eligible for a treatment by everolimus in association with the exemestane
  • Performance status of 0,1 or 2 according to the WHO
  • Patients affected of a breast cancer advanced and\\or metastatic HER2 negative expressing the hormonal receptor RH +
  • menopausal Patients

You may not qualify if:

  • Psychiatric disease compromising the understanding of the information or the realization of the study
  • Vulnerable people according to the law (minors, adults under protection, private persons of freedom)
  • Histories of cancer in 5 years preceding the diagnosis (except breast cancer, squamous-cell)
  • Not menopausal women
  • Unaffiliated people to the Social Security
  • Hypersensitivity in the active substance, in the other by-products of the rapamycin or in one of the excipients.
  • Symptomatic visceral achievement
  • Legal incapacity or limited legal capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Régional Universitaire

Besançon, 25030, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Elsa CURTIT

CONTACT

elsa.curtit@univ-fcomte.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 3, 2016

Study Start

November 26, 2015

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

February 1, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)