NCT05680662

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 unknown EARLY_PHASE1 Last updated 11 January 2023

What this trial tests

EARLY_PHASE1 trial testing quercetin, EGCG, metformin , zinc in Breast Cancer Female in 200 participants. Status unknown.

Timeline

1 January 2023

Primary endpoint
31 December 2023

31 January 2024

Quick facts

Lead sponsor	Ministry of Health, Saudi Arabia
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	200
Start date	1 January 2023
Primary completion	31 December 2023
Estimated completion	31 January 2024

Drugs / interventions tested

• quercetin, EGCG, metformin , zinc

Conditions studied

• Breast Cancer Female — all drugs for Breast Cancer Female →
• Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →

Sponsor

Ministry of Health, Saudi Arabia

Who can join

Adults 18 to 70, female only, with Breast Cancer Female or Triple Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
   Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3
2. Epigallocatechin-3-Gallate Therapeutic Potential in Cancer: Mechanism of Action and Clinical Implications.
   Kciuk M, Alam M, Ali N, Rashid S, et al · · 2023 · cited 72× · PMID 37446908 · DOI 10.3390/molecules28135246
3. Metformin: A Dual-Role Player in Cancer Treatment and Prevention.
   Galal MA, Al-Rimawi M, Hajeer A, Dahman H, et al · · 2024 · cited 44× · PMID 38612893 · DOI 10.3390/ijms25074083
4. Mitochondrial metabolism and cancer therapeutic innovation.
   Du H, Xu T, Yu S, Wu S, et al · · 2025 · cited 43× · PMID 40754534 · DOI 10.1038/s41392-025-02311-x
5. Substances of Natural Origin in Medicine: Plants vs. Cancer.
   Gielecińska A, Kciuk M, Mujwar S, Celik I, et al · · 2023 · cited 39× · PMID 37048059 · DOI 10.3390/cells12070986
6. The Crosstalk between Autophagy and Nrf2 Signaling in Cancer: from Biology to Clinical Applications.
   Shan C, Wang Y, Wang Y. · · 2024 · cited 27× · PMID 39664581 · DOI 10.7150/ijbs.103187
7. Blockage of Autophagy for Cancer Therapy: A Comprehensive Review.
   Hassan AMIA, Zhao Y, Chen X, He C. · · 2024 · cited 26× · PMID 39000565 · DOI 10.3390/ijms25137459
8. Role of mitochondria in physiological activities, diseases, and therapy.
   Wang L, Zhou X, Lu T. · · 2025 · cited 23× · PMID 40536597 · DOI 10.1186/s43556-025-00284-5