In short
This article discusses the ongoing clinical trials investigating the use of Izorlisib Mesilate, also known as MEN1611, in combination with eribulin for treating advanced breast cancer. The study focuses on patients with specific genetic alterations in PIK3CA and PTEN genes, targeting both triple-negative and HR-positive/HER2-negative metaplastic breast cancers. The trials aim to assess the efficacy and safety of this combination therapy in improving outcomes for patients with limited treatment options.
At a glance
- Study Drug
- Izorlisib Mesilate (MEN1611)
- Drug Type
- Selective Class I PI3K inhibitor
- Administration
- Oral capsule, 16 mg, maximum daily dose 96 mg
- Combination Therapy
- Eribulin
- Target Population
- Advanced PIK3CA and/or PTEN-altered metaplastic or triple-negative breast cancer, and HR-positive/HER2-negative metaplastic breast cancer
- Primary Endpoint
- Clinical Benefit Rate (CBR)
- Secondary Endpoints
- Objective Response Rate (ORR), Time to Response (TTR), Duration of Response (DoR), Progression-Free Survival (PFS), Overall Survival (OS)
- Safety Assessment
- Incidence of adverse events (AEs)
- Trial Phase
- Phase II
- Trial Design
- Multicenter, two-cohort, non-comparative, open-label
What is IZORLISIB MESILATE?
IZORLISIB MESILATE, also known as MEN1611, is a new drug being studied for the treatment of advanced breast cancer. It belongs to a class of medications called selective Class I PI3K inhibitors. This means it targets a specific protein in cancer cells that helps them grow and survive.
Target Conditions
The drug is being investigated for two specific types of advanced breast cancer:
- Locally advanced or unresectable PIK3CA and/or PTEN-altered metaplastic or non-metaplastic triple-negative breast cancer.
- Locally advanced or unresectable PIK3CA and/or PTEN-altered metaplastic HR-positive/HER2-negative breast cancer.
Let's break down these terms:
- Locally advanced or unresectable: This means the cancer has spread from where it started but is not yet widespread throughout the body. "Unresectable" means it cannot be completely removed by surgery.
- PIK3CA and PTEN: These are genes that, when altered, can contribute to cancer growth.
- Metaplastic: A rare and aggressive type of breast cancer.
- Triple-negative: A type of breast cancer that lacks three common receptors (estrogen, progesterone, and HER2).
- HR-positive/HER2-negative: Cancer cells that have hormone receptors but lack HER2 receptors.
How It Works
IZORLISIB MESILATE works by inhibiting a group of enzymes called PI3K (phosphatidylinositol-3-kinase). These enzymes are part of a signaling pathway that is often overactive in cancer cells, leading to uncontrolled cell growth and survival. By blocking this pathway, IZORLISIB MESILATE aims to slow down or stop cancer growth.
Clinical Trial Details
The drug is currently being studied in a Phase II clinical trial called the SABINA study. This trial is:
- Multicenter: Conducted at multiple hospitals or research centers
- Two-cohort: Studying two groups of patients with different types of breast cancer
- Non-comparative: Not directly comparing the treatment to another therapy
- Open-label: Both patients and doctors know which treatment is being given
In this trial, IZORLISIB MESILATE is being combined with another drug called eribulin.
Eligibility Criteria
To participate in the trial, patients must meet certain criteria, including:
- Be 18 years or older
- Have confirmed PIK3CA mutation or PTEN loss in their tumor
- Have received at least one, but no more than four, prior lines of systemic therapy for advanced disease
- Have adequate organ function and performance status
There are also several exclusion criteria, such as certain medical conditions or prior treatments, that would prevent participation.
Potential Benefits
The main goals of the study are to assess:
- Clinical Benefit Rate (CBR): The percentage of patients whose cancer shrinks or remains stable for at least 12 weeks
- Objective Response Rate (ORR): The proportion of patients whose tumors shrink significantly
- Duration of Response (DoR): How long the tumor response lasts
- Progression-Free Survival (PFS): How long patients live without their cancer getting worse
- Overall Survival (OS): How long patients live overall
Safety Considerations
As with any new treatment, there may be side effects or risks. The study will closely monitor patients for any adverse events. Some potential areas of concern include:
- Effects on blood cell counts
- Liver and kidney function
- Heart rhythm changes
- Gastrointestinal issues
It's important to note that IZORLISIB MESILATE is still in the research phase. While it shows promise, more studies are needed to fully understand its effectiveness and safety profile for treating advanced breast cancer.