Ignite Creation Date:
2024-05-06 @ 12:20 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01556191
Status:
COMPLETED
Last Update Posted:
2021-01-08
First Post:
2012-03-08
Brief Title:
Lung Cancer in Women Treated With Anti-oestrogens anD Inhibitors of EGFR
Sponsor:
Intergroupe Francophone de Cancerologie Thoracique
Organization:
Intergroupe Francophone de Cancerologie Thoracique
Study Overview
Official Title:
Phase II Randomised Clinical Trial Evaluating an EGFR Tyrosine Kinase Inhibitor EGFR-TKI Versus an EGFR-TKI Combined With an Anti-oestrogen Treatment Fulvestrant in Women With Advanced Stage Non-squamous Lung Cancer
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LADIE
Brief Summary:
Lung Cancer is to become the first cause of death related to cancer in France as its already the case in United States At Present Lung Cancer in women and in men is treated similarly Nevertheless numerous studies shows that lung cancer in women has specificities at the time of the diagnosis female patients are younger there are less clinical signs clinical stages are earlier histology is often adenocarcinoma The link with tabagism is weaker Sensitivity to tabagism is higher more cancer in women with the same tabagism Response rate to chemotherapy is better Prognosis is better
Numerous hypotheses have been put forward to account for the specific characteristics of female lung cancer described above
One hypothesis is that there are different genetic anomalies in women Some studies show an increase of EGFR mutation and HER2 expression and a decrease of expression of repair enzymes ERCC1 RRM1 BRCA which can explain the increase sensitivity to tabagism and to chemotherapy
Another hypothesis is that hormones play a role in oncogenesis Indeed lung cancer presents hormonal risk factors pre-menopause less than 3 kids short menstrual cycle hormone replacement therapy Estrogens would have a deleterious effect on cancer incidence and on survival of lung cancer in women Cellular and animal models show that ER pathway is activated in lung cancer and participates in oncogenesis
Moreover an interaction between RE and EGFR pathway has been demonstrated on lung cancer cell lines and mouse models
EGFR-TKI have shown benefit in women with wild type EGFR or unknown status with erlotinib and in women with EGFR mutations with gefitinib In this study the use of these two treatment will be in accordance with their market authorisations
The objective of this study is to test the addition of an anti-estrogen fulvestrant to EGFR-TKI Fulvestrant is a pure anti-oestrogen that binds to ER blocks it and accelerates its breakdown It has a market authorisation in breast cancer Furthermore the association between EGFR-TKI and anti-estrogen could have a synergetic effect due to interaction between RE and EGFR pathways
Numerous hypotheses have been put forward to account for the specific characteristics of female lung cancer described above
One hypothesis is that there are different genetic anomalies in women Some studies show an increase of EGFR mutation and HER2 expression and a decrease of expression of repair enzymes ERCC1 RRM1 BRCA which can explain the increase sensitivity to tabagism and to chemotherapy
Another hypothesis is that hormones play a role in oncogenesis Indeed lung cancer presents hormonal risk factors pre-menopause less than 3 kids short menstrual cycle hormone replacement therapy Estrogens would have a deleterious effect on cancer incidence and on survival of lung cancer in women Cellular and animal models show that ER pathway is activated in lung cancer and participates in oncogenesis
Moreover an interaction between RE and EGFR pathway has been demonstrated on lung cancer cell lines and mouse models
EGFR-TKI have shown benefit in women with wild type EGFR or unknown status with erlotinib and in women with EGFR mutations with gefitinib In this study the use of these two treatment will be in accordance with their market authorisations
The objective of this study is to test the addition of an anti-estrogen fulvestrant to EGFR-TKI Fulvestrant is a pure anti-oestrogen that binds to ER blocks it and accelerates its breakdown It has a market authorisation in breast cancer Furthermore the association between EGFR-TKI and anti-estrogen could have a synergetic effect due to interaction between RE and EGFR pathways
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None