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Elacestrant Dihydrochloride

Elacestrant Dihydrochloride, also known as RAD1901, is a promising drug being studied in various clinical trials. These trials aim to evaluate its effectiveness in treating different conditions, including breast cancer and menopausal symptoms like hot flashes. The studies range from early-phase pharmacokinetic assessments to more advanced trials combining Elacestrant with other cancer treatments. This article summarizes the key findings and objectives of these clinical trials, providing insights into the potential applications of Elacestrant in medical treatment.

Table of Contents

What is Elacestrant?

Elacestrant dihydrochloride, also known as RAD1901 or by its brand name ORSERDU, is a medication that has been developed to treat various conditions, primarily focusing on breast cancer and menopausal symptoms[1][2]. It belongs to a class of drugs called selective estrogen receptor degraders (SERDs), which work by targeting and breaking down estrogen receptors in the body[4].

Elacestrant in Breast Cancer Treatment

Elacestrant is being studied as a treatment for metastatic breast cancer, which is cancer that has spread from the breast to other parts of the body. Specifically, it targets hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer[2]. This type of breast cancer is driven by hormones like estrogen, and elacestrant works by interfering with the cancer cells’ ability to use these hormones for growth.

Clinical trials are investigating the effectiveness of elacestrant in combination with other drugs, such as samuraciclib, for treating advanced breast cancer. These studies aim to determine if this combination can improve outcomes for patients who have not responded well to other treatments[2].

Elacestrant for Menopausal Symptoms

In addition to its potential in cancer treatment, elacestrant has been studied for its effects on menopausal symptoms, particularly hot flashes (also known as vasomotor symptoms). Hot flashes are sudden feelings of warmth, often accompanied by sweating and flushing, that are common during menopause[3][3].

Clinical trials have explored different doses of elacestrant to determine its effectiveness in reducing the frequency and severity of hot flashes in postmenopausal women. These studies have looked at various aspects, including:

  • Changes in the number of moderate to severe hot flashes per day
  • Changes in the severity of hot flashes
  • Overall improvement in menopausal symptoms

The results of these studies may help determine if elacestrant could be a viable treatment option for women experiencing troublesome menopausal symptoms[5].

Ongoing Research and Clinical Trials

Several clinical trials are currently underway to further investigate the potential of elacestrant in various medical applications:

  • Pharmacokinetic studies: These studies look at how the body processes elacestrant, including its absorption, distribution, and elimination. One trial is specifically examining how liver function affects the drug’s behavior in the body[1].
  • Combination therapy studies: Researchers are exploring how elacestrant works when combined with other cancer treatments, such as samuraciclib, to potentially enhance its effectiveness against breast cancer[2].
  • Imaging studies: Some trials are using advanced imaging techniques, such as positron emission tomography (PET) scans, to visualize how elacestrant interacts with estrogen receptors in breast cancer cells. This can help researchers better understand how the drug works and predict which patients might benefit most from the treatment[4].

Potential Side Effects and Safety

As with any medication, elacestrant may cause side effects. Clinical trials are carefully monitoring patients for any adverse reactions to ensure the drug’s safety. Some of the aspects being evaluated include:

  • Changes in vital signs and laboratory test results
  • Effects on heart function through electrocardiogram (ECG) monitoring
  • Impact on overall health status and daily activities
  • Any unexpected or serious adverse events

It’s important to note that the full safety profile of elacestrant is still being established through ongoing research. Patients considering this treatment should discuss potential risks and benefits with their healthcare provider[2][5].

Aspect Details
Drug Name Elacestrant Dihydrochloride (RAD1901, ORSERDU)
Primary Conditions Studied Metastatic Breast Cancer, Locally Advanced Breast Cancer, Vasomotor Symptoms (Hot Flashes)
Trial Phases Phase 1, Phase 1b, Phase 2, Phase 2b
Administration Oral, once daily
Dosage Range 5 mg to 400 mg per day (varies by study)
Key Outcomes Measured Pharmacokinetics, Safety, Tolerability, Progression-Free Survival, Hot Flash Frequency and Severity
Combination Therapies Studied in combination with Samuraciclib in some trials
Special Populations Postmenopausal women, Patients with hepatic impairment
Imaging Techniques Used 16α-18F-Fluoro-17β-estradiol (FES) Positron Emission Tomography (PET)
Duration of Studies Ranges from 28 days to 12 months, depending on the study

FAQ

  • What is Elacestrant Dihydrochloride? Elacestrant Dihydrochloride, also known as RAD1901 or ORSERDU, is a drug being studied for its potential in treating various conditions, primarily breast cancer and menopausal symptoms like hot flashes. It is classified as a selective estrogen receptor degrader (SERD).
  • What types of conditions is Elacestrant being studied for? Elacestrant is being studied for multiple conditions, including metastatic breast cancer, locally advanced breast cancer, and vasomotor symptoms (hot flashes) in postmenopausal women.
  • How is Elacestrant administered in clinical trials? In the clinical trials reviewed, Elacestrant is typically administered orally, once daily. The dosage varies depending on the study, ranging from 5 mg to 400 mg per day.
  • Are there any notable side effects of Elacestrant observed in trials? While specific side effects are not detailed in the provided trial summaries, safety and tolerability are being assessed in various studies. This includes monitoring adverse events, changes in vital signs, and laboratory values.
  • How long do the clinical trials for Elacestrant typically last? The duration of clinical trials for Elacestrant varies. Some studies last for a few weeks, while others continue for several months or even up to a year, depending on the specific objectives and design of each trial.

Ongoing Clinical Trials on Elacestrant Dihydrochloride

  • Evaluating Elacestrant alone or with leuprorelin in premenopausal women with early-stage hormone receptor positive breast cancer before surgery

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Adding Elacestrant to Olaparib for Patients with HR-Positive, HER2-Negative Advanced Breast Cancer with gBRCA1/2 Mutations

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Elacestrant and Triptorelin for Premenopausal Women with Early Luminal Breast Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Elacestrant Dihydrochloride: A drug also known as RAD1901 or ORSERDU, being studied for its potential in treating breast cancer and menopausal symptoms. It is classified as a selective estrogen receptor degrader (SERD).
  • Metastatic Breast Cancer: A stage of breast cancer where the cancer has spread beyond the breast to other parts of the body.
  • Hormone Receptor (HR) positive: A type of breast cancer that has receptors for either estrogen or progesterone, making it responsive to hormone therapy.
  • Human Epidermal Growth Factor Receptor 2 (HER2) negative: A characteristic of breast cancer cells that do not have a protein called HER2 on their surface.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Vasomotor Symptoms: Physical symptoms such as hot flashes and night sweats, commonly experienced during menopause.
  • Estrogen Receptor (ER): A protein found in certain cancer cells that binds to the hormone estrogen, potentially stimulating the growth of these cells.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease but it does not get worse.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to assess changes in tumor size during cancer treatment.
  • Follicle Stimulating Hormone (FSH): A hormone involved in the development of eggs in women and sperm in men, often measured to assess menopausal status.

References

  1. https://clinicaltrials.gov/study/NCT06126575
  2. https://clinicaltrials.gov/study/NCT05963997
  3. https://clinicaltrials.gov/study/NCT00875420
  4. https://clinicaltrials.gov/study/NCT02650817
  5. https://clinicaltrials.gov/study/NCT02653417