Not recruiting

Study on the Safety of ARV-471 and Everolimus for Patients with Advanced or Metastatic ER+, HER2- Breast Cancer

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of breast cancer known as ER-positive, HER2-negative advanced or metastatic breast cancer. This type of cancer is characterized by the presence of estrogen receptors (ER-positive) and the absence of human epidermal growth factor receptor 2 (HER2-negative), which can influence how the cancer grows and responds to treatment. The study is testing a new treatment combination that includes a medication called ARV-471 and another medication known as Everolimus. Everolimus is already used in some cancer treatments, and ARV-471 is being studied to see how well it works with Everolimus.

The purpose of the study is to evaluate the safety and tolerability of the combination of ARV-471 and Everolimus. Participants in the study will receive these medications in the form of tablets that are taken orally. The study will monitor participants for any side effects and determine the best dose of the combination treatment. The trial will also look at how the cancer responds to the treatment over time.

Participants will be closely monitored throughout the study to ensure their safety and to gather information on how the treatment affects their cancer. The study aims to find out if this combination of medications can be a safe and effective treatment option for people with ER-positive, HER2-negative advanced or metastatic breast cancer. The trial is expected to continue until 2025, with the goal of providing valuable insights into this potential treatment option.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, medical history, and current health status.
Participants must have a confirmed diagnosis of ER+, HER2- advanced or metastatic breast cancer.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the current health status and medical history.
This includes a review of previous treatments and current medications.
Step 3
Treatment phase
Participants receive a combination of ARV-471 and everolimus.
ARV-471 is administered in the form of a film-coated tablet, taken orally.
Everolimus is available in two dosages: 2.5 mg and 5 mg tablets, also taken orally.
The specific dosage and frequency are determined by the study team based on individual needs and responses.
Step 4
Monitoring and evaluation
Regular monitoring is conducted to assess the safety and tolerability of the treatment.
This includes tracking any side effects or adverse reactions.
Laboratory tests and imaging studies may be performed to evaluate the response to treatment.
Step 5
Completion of treatment
The treatment phase continues until the study's end date or until it is determined that the treatment is no longer beneficial.
Participants are evaluated for any long-term effects and overall outcomes.

Who can join the trial?

10 criteria

Patients must be at least 18 years old.
Patients must have a confirmed diagnosis of **ER+** and **HER2-** advanced breast cancer. This means the cancer is either metastatic (spread to other parts of the body), recurrent (come back after treatment), or cannot be removed by surgery. **ER+** means the cancer grows in response to the hormone estrogen, and **HER2-** means the cancer does not have high levels of the protein HER2.
Women must fit into one of these categories:
- **Postmenopausal women**: Women who have had both ovaries removed, are 60 years or older, or are under 60 but have not had a menstrual period for at least 12 months without certain treatments affecting their periods.
- **Pre- and peri-menopausal women**: Women who are still having periods or are in the transition phase must be on ovarian suppression treatment for at least 4 weeks before starting the study and continue for 8 weeks after the last dose.
- Patients must have either measurable disease (tumors that can be measured) or non-measurable disease that can still be evaluated, according to specific guidelines called **RECIST 1.1**.
- Patients must have an **ECOG performance status** of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
- Patients must have received between 1 to 3 previous treatments for advanced or metastatic cancer:
  - They must have tried and either not responded to or could not tolerate a **CDK 4/6 inhibitor**, a type of cancer treatment.
  - They must have received at least one **endocrine therapy**, which is a hormone treatment.
  - They may have had up to one line of chemotherapy.
  - Patients must be willing and able to take oral medication without crushing, dissolving, or chewing the tablets or capsules.

Who cannot join the trial?

4 criteria

Patients who do not have **ER+** (Estrogen Receptor Positive) and **HER2–** (Human Epidermal growth factor Receptor 2 Negative) advanced or metastatic breast cancer cannot participate.
Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who do not meet other specific health criteria set by the study cannot participate. These criteria are usually detailed in the study's guidelines.

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Investigated drugs

ARV-471
is an investigational medication being studied for its potential to treat advanced or metastatic breast cancer that is positive for estrogen receptors (ER+) and negative for human epidermal growth factor receptor 2 (HER2-). It is being tested to see how safe and tolerable it is when used in combination with another medication.
Everolimus
is a medication that is already used to treat certain types of cancer. In this trial, it is being combined with ARV-471 to see if the combination is safe and effective for patients with ER+, HER2- advanced or metastatic breast cancer. Everolimus works by interfering with cancer cell growth and spread.

What is already known about the treatment

ARV-471
ARV-471 is administered orally and is currently being studied in clinical trials for its potential use in treating ER+, HER2– advanced or metastatic breast cancer. It is in the investigational stage, with ongoing research to evaluate its safety and effectiveness. The medication works by targeting and degrading estrogen receptors, which are involved in the growth of certain breast cancer cells. ARV-471 is classified as a selective estrogen receptor degrader (SERD).
Everolimus
Everolimus is taken orally and is an established medication used in various cancer treatments, including breast cancer. It is being studied in combination with ARV-471 to assess its safety and optimal dosing. Everolimus works by inhibiting the mTOR pathway, which is crucial for cell growth and proliferation. It is classified as an mTOR inhibitor.

Investigated diseases

ER+, HER2– Advanced or Metastatic Breast Cancer – This type of breast cancer is characterized by the presence of estrogen receptors (ER+) and the absence of human epidermal growth factor receptor 2 (HER2–). It typically occurs when cancer cells have spread beyond the breast to other parts of the body, such as bones, liver, or lungs. The progression of this cancer can vary, but it often involves the growth and spread of cancer cells that rely on estrogen to grow. As the disease advances, it may lead to symptoms such as bone pain, fatigue, and weight loss. The cancer's behavior can be influenced by hormonal changes, and it may respond to treatments that target hormone receptors.