In short
Alisertib Sodium is being studied in clinical trials as a potential treatment for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) recurrent or metastatic breast cancer. This article will explore the ongoing research, including the drug's combination with hormone therapy, its potential benefits, and what patients should know about participating in these trials.
At a glance
- Drug Name
- Alisertib Sodium
- Trial Phase
- Phase 2
- Target Condition
- HR+, HER2- recurrent or metastatic breast cancer
- Treatment Combination
- Alisertib Sodium with endocrine therapy
- Main Objectives
- Determine optimal dose, assess safety and efficacy, evaluate biomarkers and pharmacokinetics
- Key Eligibility Criteria
- Age ≥18, HR+/HER2- breast cancer, prior treatment with endocrine therapy and CDK4/6 inhibitor
- Primary Endpoints
- Adverse events, objective response rate, duration of response, disease control rate, progression-free survival, overall survival
- Drug Administration
- Oral tablets, maximum daily dose 100 mg, treatment period up to 28 days
What is Alisertib Sodium?
Alisertib Sodium is an investigational drug being studied for the treatment of advanced breast cancer. It is also known by its product name "Alisertib Enteric-Coated Tablets." This medication is currently being tested in clinical trials to determine its effectiveness and safety for patients with specific types of breast cancer.
How Does Alisertib Sodium Work?
Alisertib Sodium is classified as an Aurora Kinase A (AURKA) inhibitor. Aurora kinases are enzymes that play a crucial role in cell division. By targeting and inhibiting these enzymes, Alisertib Sodium may help slow down or stop the growth of cancer cells. This approach is different from traditional chemotherapy and may offer new hope for patients who have not responded well to other treatments.
Who Might Benefit from Alisertib Sodium?
Alisertib Sodium is being studied specifically for patients with:
- Hormone receptor-positive (HR+) breast cancer: This means the cancer cells grow in response to hormones like estrogen or progesterone.
- Human epidermal growth factor receptor 2-negative (HER2-) breast cancer: This means the cancer cells do not have high levels of a protein called HER2.
- Recurrent or metastatic breast cancer: This refers to cancer that has either come back after initial treatment or has spread to other parts of the body.
Importantly, this treatment is being studied for patients who have already tried at least two other hormone therapies and a CDK4/6 inhibitor (another type of targeted therapy) for their advanced breast cancer.
Current Clinical Trial
A Phase 2 clinical trial is currently underway to study Alisertib Sodium in combination with hormone therapy for patients with HR+, HER2- recurrent or metastatic breast cancer. The main goals of this study are to:
- Determine the best dose of Alisertib Sodium when used with hormone therapy
- Assess how well the combination works in treating the cancer
- Evaluate the safety of the treatment
The study will also look at how the drug behaves in the body (pharmacokinetics) and whether there are any biological markers that can predict which patients might respond best to the treatment.
Eligibility Criteria
To participate in the clinical trial, patients must meet specific criteria. Some key eligibility requirements include:
- Being 18 years or older
- Having HR+, HER2- breast cancer that has recurred or spread
- Having tried at least two previous hormone therapies and a CDK4/6 inhibitor
- Having at least one measurable tumor
- Being in generally good health with adequate organ function
There are also several exclusion criteria, such as having certain heart conditions, active infections, or brain metastases that are not well-controlled.
Potential Side Effects
As with any medication, Alisertib Sodium may cause side effects. The clinical trial is carefully monitoring for any adverse events. Some potential side effects that are being watched for include:
- Changes in heart rhythm (QT prolongation)
- Decreased heart function
- Digestive system issues
- Blood clots
- Interactions with other medications
It's important to note that the full range of potential side effects is still being studied.
Future Research and Availability
Alisertib Sodium is still in the research phase and is not yet approved for general use. The results of this clinical trial will help determine if further studies are needed and whether the drug might eventually become available as a treatment option for patients with advanced breast cancer.
Puma Biotechnology, the company developing Alisertib Sodium, has committed to sharing the results of this study to help advance scientific knowledge and inform treatment decisions.