Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06033092
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2023-08-23
Brief Title:
Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion a Randomized Phase II Biomarker Trial in Subjects at Increased Risk
Status:
RECRUITING
Status Verified Date:
2024-06
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:
TOLERANT
Brief Summary:
Circulating levels of Sex Hormone Binding Globulin SHBG are significantly associated with a decreased risk of breast cancer
The main aim of this clinical trial is to verify whether Low Dose Tamoxifen LDT increases circulating levels of SHBG more than lifestyle intervention LI with or without intermittent caloric restriction ICR after 6 months in women at increased risk of breast cancer ie healthy participants carriers of a germline pathogeniclikely pathogenetic variant in at least one of the following genes BRCA1 BRCA2 PALB2 ATM CHEK2 CDH1 RAD51C or RAD51D or with 5 breast cancer risk at 10 years using the Tyrer Cuzick or the Breast Cancer Surveillance Consortium Risk models or with a recently resected intraepithelial neoplasia of the breast IEN
The secondary aims are
to verify whether ICR significantly modulates primary and secondary endpoints such as Homeostasis Model Assessment HOMA index immune and inflammatory markers lipid profile AdiponectinLeptin AL ratio quality of life QoL Body mass index BMI fat body composition safety and toxicity
to verify whether LDT significantly modulates secondary endpoints such as HOMA-index immune and inflammatory markers lipid profile AL ratio QoL BMI fat body composition safety and toxicity
to investigate differences in microbiome composition by arms and the effect of changes in microbiome on QoL taking into account circulating biomarkers cytokines immune modulators and inflammatory proteins in serum
to investigate MD Mammographic Breast Density changes by LDT vs LI with or without ICR This aim will be performed in a subgroup of participants not all the participants will undergo mammography due to younger age
The main aim of this clinical trial is to verify whether Low Dose Tamoxifen LDT increases circulating levels of SHBG more than lifestyle intervention LI with or without intermittent caloric restriction ICR after 6 months in women at increased risk of breast cancer ie healthy participants carriers of a germline pathogeniclikely pathogenetic variant in at least one of the following genes BRCA1 BRCA2 PALB2 ATM CHEK2 CDH1 RAD51C or RAD51D or with 5 breast cancer risk at 10 years using the Tyrer Cuzick or the Breast Cancer Surveillance Consortium Risk models or with a recently resected intraepithelial neoplasia of the breast IEN
The secondary aims are
to verify whether ICR significantly modulates primary and secondary endpoints such as Homeostasis Model Assessment HOMA index immune and inflammatory markers lipid profile AdiponectinLeptin AL ratio quality of life QoL Body mass index BMI fat body composition safety and toxicity
to verify whether LDT significantly modulates secondary endpoints such as HOMA-index immune and inflammatory markers lipid profile AL ratio QoL BMI fat body composition safety and toxicity
to investigate differences in microbiome composition by arms and the effect of changes in microbiome on QoL taking into account circulating biomarkers cytokines immune modulators and inflammatory proteins in serum
to investigate MD Mammographic Breast Density changes by LDT vs LI with or without ICR This aim will be performed in a subgroup of participants not all the participants will undergo mammography due to younger age
Detailed Description:
Italian multicenter phase II biomarker trial A total of 200 women aged 18-70 years will be randomly assigned 1111 to one of the four intervention arms Arm 1 Low dose Tamoxifen LDT ie 10 mg every other day Arm 2 Low dose Tamoxifen LDT Intermittent Caloric Restriction ICR Arm 3 Lifestyle intervention LI using a step counter Arm 4 Lifestyle intervention LI using a step counter Intermittent Caloric Restriction ICR
Participants will be stratified by center and by disease status high risk vs previous IEN and intervention will last six months for all arms
Participants will be stratified by center and by disease status high risk vs previous IEN and intervention will last six months for all arms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-503994-39-00 | OTHER | EU CT number | None |