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Study Comparing ARV-471 and Palbociclib with Letrozole and Palbociclib for Patients with Estrogen Receptor Positive, HER2-Negative Advanced 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 treatments for Estrogen Receptor Positive, HER2-Negative Advanced Breast Cancer. The study will compare two different treatment combinations. One group will receive a combination of ARV-471 (also known as PF-07850327) and palbociclib, while the other group will receive letrozole and palbociclib. Palbociclib is a medication that helps to slow down the growth of cancer cells, and it is taken in the form of capsules. ARV-471 is a new medication being tested in this study, and letrozole is a commonly used treatment for breast cancer.

The purpose of this study is to determine if the combination of ARV-471 and palbociclib is more effective than the combination of letrozole and palbociclib in delaying the progression of the disease. Participants in the study will be randomly assigned to one of the two treatment groups. The study will be conducted over a period of time, and participants will receive their assigned treatment orally, in the form of capsules or tablets. The study will monitor the participants' health and the progression of their cancer to evaluate the effectiveness of the treatments.

Throughout the study, participants will have regular check-ups to assess their response to the treatment and to monitor for any side effects. The study aims to provide valuable information on the best treatment options for individuals with Estrogen Receptor Positive, HER2-Negative Advanced Breast Cancer who have not received any prior systemic anti-cancer treatment for their advanced disease. This research could potentially lead to improved treatment strategies for this type of breast cancer.

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 provide a blood sample and a tumor sample, unless they have bone-only disease, in which case an archival tumor sample is acceptable.
Step 2
Initial treatment phase
Participants are randomly assigned to receive either ARV-471 plus palbociclib or letrozole plus palbociclib.
Palbociclib is administered orally in the form of hard capsules, with available dosages of 75 mg and 100 mg.
Step 3
Treatment administration
The treatment involves taking the assigned medication daily, with the specific dosage and frequency determined by the study protocol.
Participants are monitored for any side effects or adverse events, with particular attention to neutropenia, a condition involving low levels of neutrophils, a type of white blood cell.
Step 4
Monitoring and assessment
Regular assessments are conducted to monitor the progression of the disease and the participant's response to the treatment.
These assessments include imaging tests and blood tests to evaluate the effectiveness of the treatment and any potential side effects.
Step 5
End of treatment evaluation
At the end of the treatment period, a final evaluation is conducted to assess the overall response to the treatment.
The primary goal is to determine progression-free survival, which measures the length of time during and after treatment that the disease does not worsen.

Who can join the trial?

10 criteria

Participants must be 18 years or older at the time of screening.
Pre-peri menopausal females and males must agree to use a medication called LHRH.
Women of childbearing potential and male participants must agree to use contraception.
Participants must provide a blood sample and a tumor sample collected at the time of diagnosis of advanced disease. If not available, a new biopsy is required. For those with bone-only disease, an older tumor sample is acceptable.
Participants must have a confirmed diagnosis of breast cancer that is locally advanced or metastatic, meaning it has spread and cannot be treated with surgery or radiation to cure it.
The cancer must be ER(+), which means it has estrogen receptors on at least 1% of the cells, and HER2(-), meaning it does not have HER2 receptors. This must be confirmed by a test.
Participants with bilateral breast cancers (cancer in both breasts) that are both ER(+) and HER2(-) are eligible.
No previous systemic anti-cancer therapy for their advanced disease is allowed.
Participants must have at least one measurable lesion as defined by specific criteria. For those with bone-only disease, non-measurable lesions are acceptable.
Participants must have an ECOG performance status of 0, 1, or 2, which is a scale used to assess how well a person can perform daily activities.

Who cannot join the trial?

4 criteria

Patients who have received any prior systematic anticancer therapy for their advanced disease cannot participate. This means if you have already been treated with medications that affect the whole body for your advanced cancer, you are not eligible.
Patients who are not diagnosed with ER+/HER2- Advanced Breast Cancer are excluded. This refers to a specific type of breast cancer that tests positive for estrogen receptors (ER+) and negative for human epidermal growth factor receptor 2 (HER2-).
Patients who do not fall within the specified age range are not eligible. The age range is typically defined by the study, so it's important to check if you fit within it.
Patients who are part of a vulnerable population are not eligible. This generally includes groups who may have limited ability to give informed consent or are at higher risk of harm.

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Verified sites

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

Verified
Fondazione IRCCS San Gerardo Dei Tintori
Monza, Italy
Verified
Hospital Clinico San Carlos
Madrid, Spain
Responsive
Hospital Universitario De Jaen
Jaen, Spain

Trial locations

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Investigated drugs

ARV-471 (PF-07850327)
is an investigational medication being studied for its potential to treat breast cancer. It is being tested in combination with another medication to see if it can help slow down the progression of the disease in patients who have not yet received any other treatments for their advanced breast cancer.
Palbociclib
is a medication used in the treatment of certain types of breast cancer. It works by inhibiting specific proteins that are involved in the growth and division of cancer cells. In this study, it is being used in combination with other medications to evaluate its effectiveness in prolonging the time before the cancer progresses.
Letrozole
is a medication commonly used to treat breast cancer in postmenopausal women. It works by reducing the amount of estrogen in the body, which can help slow or stop the growth of certain types of breast cancer cells. In this trial, it is being compared to another treatment combination to assess its effectiveness in managing advanced breast cancer.

What is already known about the treatment

ARV-471
ARV-471 is an investigational medication administered orally, currently being studied in clinical trials for its potential use in treating estrogen receptor-positive, HER2-negative advanced breast cancer. It is not yet approved for general medical use, but it is being evaluated for its effectiveness in combination with palbociclib. The main therapeutic indication is for patients who have not received prior systemic anti-cancer treatment for advanced disease. ARV-471 works by targeting and degrading the estrogen receptor, which is crucial for the growth of certain breast cancer cells. It is classified as a selective estrogen receptor degrader (SERD).
Palbociclib
Palbociclib is an oral medication that is already approved and used in the treatment of certain types of breast cancer, specifically estrogen receptor-positive, HER2-negative advanced breast cancer. It is often used in combination with other therapies, such as ARV-471 or letrozole, to enhance treatment effectiveness. Palbociclib works by inhibiting cyclin-dependent kinases 4 and 6 (CDK4/6), which are proteins that help control cell division. By blocking these proteins, palbociclib can slow down the growth of cancer cells. It is classified as a CDK4/6 inhibitor.

Investigated diseases

ER+/HER2- Advanced 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 when it has spread beyond the breast and nearby lymph nodes to other parts of the body. The cancer cells grow in response to estrogen, which can fuel the progression of the disease. As the disease advances, it may lead to symptoms such as lumps in the breast, changes in breast shape, or pain. The progression can vary, with some cases remaining stable for long periods, while others may progress more rapidly.