Viewing Study NCT05680662



Ignite Creation Date: 2024-05-06 @ 6:29 PM
Last Modification Date: 2024-10-26 @ 2:49 PM
Study NCT ID: NCT05680662
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-01-11
First Post: 2022-12-23

Brief Title: The Study of Quadruple Therapy Quercetin Zinc Metformin and EGCG as Adjuvant Therapy for Early Metastatic Breast Cancer and Triple-negative Breast Cancer a Novel Mechanism
Sponsor: Ministry of Health Saudi Arabia
Organization: Ministry of Health Saudi Arabia

Study Overview

Official Title: The Study of Quadruple Therapy Quercetin Zinc Metformin and EGCG as Adjuvant Therapy for Early Metastatic Breast Cancer and Triple-negative Breast Cancer a Novel Mechanism
Status: NOT_YET_RECRUITING
Status Verified Date: 2022-12
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: None
Brief Summary: breast cancer is the most common cancer in women With more than 1 in 10 new cancer diagnoses each year It is the second most frequent cancer-related death among women worldwide Breast cancer develops slowly and the majority of cases are found through routine screening

breast cancer-causing deaths among women all over the world and increased in the last few years even though the treatment is advanced like immunotherapy chemotherapy by yet no treatment for triple-negative breast cancer zinc and competition between znt1 and zip610 at breast cancer cells Is zinc ionophore like quercetin and EGCG has a role In a novel experimental study zinc is a trace metal that has many roles in cells enzymatic activity and gene regulations and also for the integrity of DNA

Zinc transporters zinc related -proteins such as ZIPs and ZnTs are affected by triggers factors like cytokines and growth factors

There are two large families of zinc transporters like ZIPs 14 members and ZnTs family 10 members ZIPS family cause an influx of zinc from the extracellular to the cytoplasm and also from intracellular organelles like endoplasmic reticulum or Golgi or mitochondria in contrast to ZnTs which cause an influx of zinc from the cytoplasm to intracellular organelles lower cytoplasmic zinc 1 Breast cancer deaths occurred from metastasis Catalytic enzymes called proteases like cathepsin L are frequently overexpressed in aggressive cancers Breast tumor metastatic potential is correlated with macrophage presence These macrophages associated with tumors frequently adopt an M2-like pro-tumorigenic phenotype which results in the production of growth hormones and proteases notably the lysosomal protease cathepsin L Because cathepsin L is commonly released by breast cancer cells and aids in tumor invasion metastasis and angiogenesis It is expected that cathepsin L secretion by both tumor-associated macrophages and neoplastic cells would promote the metastatic phenotype because cathepsin L is widely produced by breast cancer cells and helps with tumor invasion metastasis and angiogenesis 2 this study target new mechanisms and achieves the best management as some types of cancer breast like triple-negative breast cancer TNBC no definite treatment so we target the following pathways and epigenetic processes by these adjuvant compounds which have a promising role in the immunity like EGCG Quercetin Zinc Metformin so our team will discuss novel methods to achieve the best efficacy from chemotherapy
Detailed Description: breast cancer is the most common cancer in women With more than 1 in 10 new cancer diagnoses each year It is the second most frequent cancer-related death among women worldwide Breast cancer develops slowly and the majority of cases are found through routine screening

breast cancer-causing deaths among women all over the world and increased in the last few years even though the treatment is advanced like immunotherapy chemotherapy by yet no treatment for triple-negative breast cancer zinc and competition between znt1 and zip610 at breast cancer cells Is zinc ionophore like quercetin and EGCG has a role In a novel experimental study zinc is a trace metal that has many roles in cells enzymatic activity and gene regulations and also for the integrity of DNA

Zinc transporters zinc related -proteins such as ZIPs and ZnTs are affected by triggers factors like cytokines and growth factors

There are two large families of zinc transporters like ZIPs 14 members and ZnTs family 10 members ZIPS family cause an influx of zinc from the extracellular to the cytoplasm and also from intracellular organelles like endoplasmic reticulum or Golgi or mitochondria in contrast to ZnTs which cause an influx of zinc from the cytoplasm to intracellular organelles lower cytoplasmic zinc 1 Breast cancer deaths occurred from metastasis Catalytic enzymes called proteases like cathepsin L are frequently overexpressed in aggressive cancers Breast tumor metastatic potential is correlated with macrophage presence These macrophages associated with tumors frequently adopt an M2-like pro-tumorigenic phenotype which results in the production of growth hormones and proteases notably the lysosomal protease cathepsin L Because cathepsin L is commonly released by breast cancer cells and aids in tumor invasion metastasis and angiogenesis It is expected that cathepsin L secretion by both tumor-associated macrophages and neoplastic cells would promote the metastatic phenotype because cathepsin L is widely produced by breast cancer cells and helps with tumor invasion metastasis and angiogenesis 2 this study target new mechanisms and achieves the best management as some types of cancer breast like triple-negative breast cancer TNBC no definite treatment so we target the following pathways and epigenetic processes by these adjuvant compounds which have a promising role in the immunity like EGCG Quercetin Zinc Metformin so our team will discuss novel methods to achieve the best efficacy from chemotherapy the study will include 100 cases with many types of breast cancer like hormonal sensitive triple negative and metastatic breast cancer and another group of 100 patients not given this adjuvant therapy type of study is a randomized clinical control trial interventional with 4 compounds EGCGZINC QUERCETINMETFORMIN

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None