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Study on the Safety and Antitumor Effects of Vepdegestrant and Abemaciclib in Adults with ER+ Advanced or Metastatic Breast Cancer

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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 and 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 investigating the effects of a new treatment combination involving two medications: Vepdegestrant (also known by its code name ARV-471 or PF-07850327) and Abemaciclib. Vepdegestrant is a type of drug called a proteolysis targeting chimera, which is designed to help break down certain proteins in cancer cells, while Abemaciclib is a medication that helps stop cancer cells from dividing and growing.

The purpose of this study is to explore the safety and effectiveness of this combination treatment in adults with this specific type of breast cancer. Participants in the study will receive the medications in the form of film-coated tablets taken orally. The study will be conducted in two phases. The first phase will focus on assessing the safety and tolerability of the treatment combination, which means checking how well participants can handle the medications and identifying any side effects. The second phase will evaluate the antitumor activity, which involves observing how well the treatment works in reducing or controlling the cancer.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to gather information on how the treatment affects their cancer. The study aims to provide valuable insights into the potential benefits of combining Vepdegestrant and Abemaciclib for treating ER-positive and HER2-negative advanced or metastatic breast cancer. The findings from this study could help improve treatment options for individuals with this type of cancer in the future.

The research process

The trial runs in 6 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, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, which means you agree to participate after understanding all the information provided.
Step 2
Initial assessment
You will undergo an initial assessment to confirm eligibility. This includes a review of your medical history, a physical examination, and possibly some laboratory tests to ensure you meet the study criteria.
Step 3
Treatment phase 1b
In this phase, you will receive a combination of two medications: ARV-471 and abemaciclib. The purpose is to assess the safety and tolerability of these medications together.
You will take abemaciclib orally in the form of film-coated tablets. The specific dosage and frequency will be determined by the study team based on your individual needs and the study protocol.
Step 4
Treatment phase 2
If you continue to the second phase, the focus will be on assessing the antitumor activity of the medication combination. This means the study will evaluate how well the treatment works against the cancer.
You will continue taking the medications as prescribed, and your response to the treatment will be closely monitored through regular check-ups and tests.
Step 5
Regular monitoring
Throughout the trial, you will have regular appointments to monitor your health and the effects of the treatment. This includes physical exams, blood tests, and imaging studies to track the progress of the cancer and any side effects you may experience.
Step 6
End of treatment
At the end of the treatment period, you will have a final assessment to evaluate the overall impact of the study medications on your condition.
You will be informed about the next steps, which may include follow-up visits to monitor your health after the trial concludes.

Who can join the trial?

7 criteria

Participants must be 18 years or older at the time of screening.
Must have a diagnosis of ER+ and HER2- Advanced or Metastatic Breast Cancer. This means the cancer has certain characteristics and has spread beyond the original site.
The cancer cannot be removed completely through surgery with the intent to cure.
Participants must have received at least 1 and no more than 2 previous treatments for advanced or metastatic cancer.
Must have had one previous treatment that included a CDK4/6 inhibitor, which is a type of cancer treatment. If this treatment was stopped due to side effects, the participant cannot join the study.
Participants must have at least one measurable tumor that can be evaluated according to specific guidelines (RECIST v1.1).
Must have an ECOG performance status of 0 or 1. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer than **ER+/HER2- Advanced or Metastatic Breast Cancer** cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
Patients who are not able to follow the study procedures or attend study visits cannot participate.
Patients who have any other medical condition that might interfere with the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a recent surgery or are planning to have surgery during the study period cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of allergic reactions to the study drugs cannot participate.
Patients who have not recovered from side effects of previous treatments cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
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Hospital Universitario 12 De Octubre
Madrid, Spain
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Hospital Universitario De Navarra
Pamplona, Spain

Trial locations

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Investigated drugs

Vepdegestrant (ARV-471/PF-07850327)
is an experimental medication being studied for its potential to treat advanced or metastatic breast cancer. It works by targeting and breaking down specific proteins in cancer cells, which may help to stop the growth of the cancer. This medication is taken orally, meaning it is swallowed in pill form. In this trial, it is being tested to see how well it works and how safe it is when used in combination with another cancer treatment.
Abemaciclib
is a medication that is already used to treat certain types of breast cancer. It works by blocking proteins that help cancer cells grow and divide. By doing this, it can slow down or stop the progression of the cancer. In this study, abemaciclib is being combined with vepdegestrant to see if the two medications together can be more effective in treating breast cancer than either one alone.

What is already known about the treatment

Vepdegestrant (ARV-471/PF-07850327) – Vepdegestrant is an oral medication currently being studied for its safety and effectiveness in treating advanced or metastatic breast cancer that is positive for estrogen receptors (ER+) and negative for human epidermal growth factor receptor 2 (HER2-). It is part of a new class of drugs called proteolysis targeting chimeras, which work by breaking down specific proteins in cancer cells to stop their growth. This medication is being tested in combination with another cancer treatment, abemaciclib, to see if it can improve outcomes for patients.

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 is considered advanced or metastatic when it has spread beyond the breast to other parts of the body. The disease progresses as cancer cells grow and multiply, potentially affecting organs such as bones, liver, lungs, or brain. The growth of these cancer cells is often driven by hormones, particularly estrogen. Over time, the cancer may become more aggressive and resistant to hormone therapies. The progression can vary significantly among individuals, with some experiencing slow growth and others facing rapid advancement.