NCT03107234

Brief Summary

Breast cancer is the leading cause of female cancer and female death by cancer in France. Despite the improvement in early detection and therapeutic arsenal, the mortality of this cancer remains high with 11 886 deaths estimated in 2012. Breast cancer is most often a carcinoma born from the lobular or ductal epithelium and is classified In two main categories: non invasive and invasive. Invasive breast cancers account for 75% of the cases. They are usually ductal (75%) and more rarely lobular (25%). The cancer cells are then no longer circumscribed to the galactophoric canals or glands but have invaded neighboring tissues. If they are not treated in time, these cancers can then spread: the cancerous cells will then migrate either by the lymphatic vessels to reach the neighboring ganglia or through the blood vessels to give metastases in other tissues In the liver, lungs and bones). The mortality associated with breast cancer is not due to the growth of the primary tumor but rather to the occurrence of metastases. The study of the mechanisms leading to metastatic invasion (i.e. migration and invasion) is therefore of considerable importance. The development of metastases depends on the acquisition by the cancer cells of various capacities including that of being able to migrate, involving a remodeling of the cytoskeleton highly dependent on the intracellular calcium (Ca2 +) concentration. Several types of signals are able to induce mobilization of Ca2 + from the extracellular medium or endoplasmic reticulum (ER) reserves. At the intracellular level, some of these signals are generated by inositol (1,4,5) -trisphosphate (IP3) from the activation of G protein-coupled receptors or certain receptors with tyrosine kinase activity. Has been shown that the expression, activity and regulation of IP3R receptors (IP3Rs) are involved in the cancerous processes of many tissues, in particular in the phenomena of proliferation of breast cancer cells. Overall, altered expression and / or activity of IP3Rs can be used for the survival, growth, proliferation and migration of cancer cells. In the laboratory, the investigator showed that regulation of the expression of subtype 3 (IP3R3) by 17β-estradiol (E2) is involved in the growth of the human mammary cancer line MCF-7. E2 triggers the release of Ca2 + in an IP3-dependent mechanism, while prolonged exposure to E2 leads to an increase in the expression of IP3R3. At the same time, the reduction in the expression of IP3R3 cancels the proliferative effect of E2 on MCF-7 cells. More recently, the investigator has established that IP3R3 regulates the proliferation of cells of the human MCF-7 mammary cancer cell line via a molecular and functional interaction with the Ca2 + -dependent BKCa potassium channel. The determination of IP3Rs, including subtype 3, as a mediator / marker of breast carcinogenesis appears to be a major clinical issue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

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

January 13, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2019

Completed
Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

4 years

First QC Date

April 5, 2017

Last Update Submit

June 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Level of expression of IP3R3 defined by an immunohistochemical score

    3 years

Study Arms (1)

Patient with breast cancer requiring surgery to

Other: Assess the level of expression of IP3R3 in cancerous tissues and healthy tissues

Interventions

Assess the level of expression of IP3R3 in cancerous tissues and healthy tissues

Patient with breast cancer requiring surgery to

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with breast cancer requiring surgery to

You may qualify if:

  • CCI / CLI to be operated
  • Grade SBR 1, 2 or 3
  • Undifferentiated RE / PR status
  • HER2 status undifferentiated
  • Ki 67 indifferent
  • Metastatic or not
  • ADP axillary invaded or not
  • Major Patients

You may not qualify if:

  • CIC / CIL
  • Males

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 11, 2017

Study Start

January 13, 2015

Primary Completion

January 22, 2019

Study Completion

January 22, 2019

Last Updated

June 12, 2026

Record last verified: 2026-06

Locations