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Trial 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
NCT ID:
NCT05680662
Condition:
Breast Cancer Female
Triple Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Metformin
Quercetin
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Combination Product
Intervention name:
quercetin, EGCG, metformin , zinc
Description:
this intervention target many mechanisms at tumorigenesis, metastasis autophagy,
apoptosis, interleukin 6, cathepsin L, and also epigenetic DNA methylation
Arm group label:
adjuvant quadruple thearpy of quercetin , zinc, EGCG, metformin for 100 breast cancer cases
Arm group label:
no adjuvant thearpy for 100 cases of breast cancer breast for this group ( controlled group )
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 zip6,10
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 zip6,10
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 (EGCG,ZINC, QUERCETIN,METFORMIN)
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age above 18
2. Female patients
3. with any type of breast cancer Ductal carcinoma in situ (DCIS) ... Invasive breast
cancer (ILC or IDC) ... Triple-negative breast cancer. ... Inflammatory breast
cancer. ... Paget disease of the breast. ... Angiosarcoma. ... Phyllodes tumor.
4. HER2-positive by ASCO CAP 2018 guidelines, confirmed by central testing
5. Participants must have normal organ and marrow function as defined below:
ANC ≥ 1000/mm3 hemoglobin ≥8 g/dl platelets ≥ 75,000/mm3 AST and ALT both <5x
institutional ULN Total bilirubin ≤ 1.5 mg/dL. For patients with Gilbert syndrome, the
direct bilirubin should be
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
January 1, 2023
Completion date:
January 31, 2024
Lead sponsor:
Agency:
Ministry of Health, Saudi Arabia
Agency class:
Other
Source:
Ministry of Health, Saudi Arabia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05680662
