Targeting Metastatic Breast Cancers by Alkaline Glucosodiene Molecules Via a Metabolic Pathway Phase I Clinical Trial

NCT05957939 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: Maher M.Akl, Amr Ahmed
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

The diverse group of breast tumors known as triple-negative breast cancer (TNBC) which is lethally and deadly type of breast cancer and insensitive to endocrine therapy and HER2-targeted therapy because it lacks the expression of estrogen, progesterone, and human epidermal growth factor receptors TNBC makes up almost 15% of all invasive breast cancers, and of all breast tumor subtypes, it has the worst overall survival and the highest rate of metastatic occurrence. Cytotoxic chemotherapy is the main established systemic therapy for early and advanced TNBC disease at the moment because there is no authorized targeted therapy. Despite the fact that chemotherapy greatly improves clinical outcomes for TNBC patients, recurrence rates are still high and TNBC cancers frequently develop chemotherapeutic drug resistance ). In light of the few available therapy choices, so few choices for this subtype of breast cancer, and many cases are resistant to chemotherapy and recurrent and with a risk of high metastasis from previous literature and many experimental studies, the target of glucose environment is a promising weapon against this deadly type of breast cancer so glucose deprivation from tumor cells may cut the glucose entry as fuel to these cancer cells so this study uses a substitute energy fuel by using alkaline glucosodiene which is chemically invented by Maher M.AKL

Conditions

TNBC - Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (2)

• the Progression-free survival (PFS)

  the time from treatment initiation until disease progression or worsening may be used as a direct or surrogate measure of clinical benefit for drug approvals, depending on the disease and response observed

  Time Frame: 30 days after treatment

• Disease-free survival (DFS)

  time from treatment until the recurrence of disease (or death) after undergoing curative-intent treatment.

  Time Frame: 30 days after treatment

Secondary Outcomes (1)

• the change in tumor size or fungating wound at the original site of tumor

  Time Frame: 30 days after treatment

Study Arms (1)

a case study with TNBC or ER positive , PR positive HER2 negative ,

EXPERIMENTAL

researchers will study a case with metastatic breast cancer stage 4 and the source of nutrition either glucose source as energy fuel of cells or another nutrition ( alkaline glucosodiene)

Drug: Alkaline Glucosodiene Molecules

Interventions

Alkaline Glucosodiene Molecules DRUG

Toxic chemotherapeutic nutrition of cancer cells by alkaline glucosodiene molecules via targeting metabolic of cancerous tumors: a promising treatment

a case study with TNBC or ER positive , PR positive HER2 negative ,

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Type of patient: Female patient
• Age: 18-55 years
• Type of breast cancer: metastatic breast cancer hormonal or triple-negative breast cancer

You may not qualify if:

• with other co-morbidities like diabetes or hypertension
• with other type of cancers
• on other chemotherapy or immunotherapy or hormonal therapy

Sponsors & Collaborators

• Ministry of Health, Saudi Arabia: lead
• Maher M.akl: collaborator

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of tuberculosis mobile team

Model Details: a case study

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 24, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share