The VERITAC-2 clinical trial will help us learn if a study medicine, ARV-471 (also known as vepdegestrant), works better than an approved therapy (fulvestrant) in prolonging the time without the disease getting worse in people with advanced breast cancer.

As you take the time to consider the next step in your breast cancer treatment journey, thank you for learning more about VERITAC-2. Participants in VERITAC-2 will receive attentive care from a skilled team of healthcare providers and could help in the discovery of a potential breakthrough medicine for people with advanced breast cancer.

Am I Eligible?

Who May Participate?

Length of Study

Who may participate

We appreciate you taking the time to learn more about VERITAC-2 as you explore your treatment options.

The VERITAC-2 clinical trial may be an option for you if:

  • You are at least 18 years old and have been diagnosed with advanced breast cancer (i.e., locoregionally advanced or metastatic disease) that
    • Expresses estrogen receptors and is called ER-positive
    • Does not express a marker, human epidermal growth factor receptor 2 (HER2) and is called HER2-negative
    • Must have been treated with a CDK4/6 inhibitor in combination with hormonal therapy. CDK4/6 inhibitors include medications called palbociclib (IBRANCE®), ribociclib (KISQALI®) and abemaciclib (Verzenio®).
    • May have been treated with 1 additional round of treatment with hormonal therapy (not required)
    • Must have worsened during or after your last therapy

If you feel this clinical trial could be right for you, answer a few questions below.

Condition

ER-positive, HER2-negative advanced breast cancer

Age

18+ years

Sex

Female or Male

Each clinical trial has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the trial.

View more eligibility criteria

Additional eligibility criteria

  • 18 years old and older
  • Have ER-positive, HER2-negative advanced breast cancer
  • Treated with a CDK4/6 inhibitor + hormonal therapy
  • May have been treated with 1 hormonal therapy in addition to the hormonal therapy given with the CDK4/6 inhibitor
  • Your cancer has worsened during or after the last therapy

*Other eligibility criteria apply

  • History of any tumor malignancies other than breast cancer within the past three years
  • Have newly diagnosed brain metastasis or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease
  • Have inflammatory breast cancer
  • Have clinically significant heart (cardiovascular) disease
  • Have kidney (renal) impairment, not adequate liver function and/or bone marrow function

*Other eligibility criteria apply

Get started — See if you may qualify

Answer a 2-minute questionnaire.

A first step as you consider this study is to answer a 2-minute online questionnaire about your health and medical history. If your answers show the study might be a good fit for you, you may choose to have your contact information shared with a Pfizer Clinical Trial Contact Center Navigator.

Speak with a study representative.

If you’re interested, a Pfizer Clinical Trial Contact Center Navigator will call you and do a more detailed review of the study and your medical history to see if you may be able to participate and be referred to a study clinic that you select.

Confirm your eligibility.

Your answers to these questions will only be linked to you if your responses indicate that you may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you. Only the study staff can determine if you meet the study’s eligibility criteria and are able to enroll in the study.

What to expect

If you choose to participate, you will review and sign the informed consent document and visit the study doctor’s office to continue with the screening period.

Tests, such as a physical exam, electrocardiogram, CT/MRI/Xray scans, and blood sample collections will be performed to confirm you meet all the eligibility criteria and are able to participate in the clinical trial.

If you qualify, you will be randomly assigned to a treatment group. You will have a 50% chance of receiving the study medicine and a 50% chance of receiving fulvestrant.

All participants in this trial will receive the study medicine or fulvestrant. Fulvestrant is an approved treatment that is currently used in people with advanced breast cancer.

Length of study treatment

You may be in the trial for up to 3 years

Number of study visits

Once every 4 weeks until treatment discontinuation

Long-term follow up

You will be contacted every 3 months

About the clinical trial treatments

All participants will receive the study medicine or fulvestrant. There is no placebo in this clinical trial.

The study medicine, ARV-471 (also known as vepdegestrant), is a type of medicine called a PROTAC protein degrader. It is believed to work by targeting and degrading the estrogen receptor that is found in breast cancer cells. This prevents estrogen from connecting to the cancer cells which may block estrogen’s effects of helping the cancer cells grow.

Fulvestrant is a medicine that is commonly used worldwide for the treatment of breast cancer.

The study medicine is taken by mouth, and fulvestrant is given as an injection (shot).

About the clinical trial treatments

Portrait of a senior, African American woman, standing in a park, leaning on a stone railing, trees out of focus in the background. She is looking away, thinking, resting her chin on the back of her hand – Pfizer Clinical Trials
Portrait of a senior, African American woman, standing in a park, leaning on a stone railing, trees out of focus in the background. She is looking away, thinking, resting her chin on the back of her hand – Pfizer Clinical Trials

Be represented

Two female friends looking at the camera and laughing while posing standing outdoors on the street – Pfizer Clinical Trials
Two female friends looking at the camera and laughing while posing standing outdoors on the street – Pfizer Clinical Trials

Be represented

People who take part in clinical trials are key to advancing medical research. By taking part in the VERITAC-2 clinical trial, you will be helping to improve scientific knowledge of breast cancer and potentially help yourself and others with breast cancer in the future.

Many factors, including genetics, race, ethnicity, and gender, can impact how people respond to medicine. That is why it is so important that clinical trials include people of all backgrounds. The greater the diversity among clinical trial participants, the more we can learn about potential medicines, including how they work for different people.

When you participate in a clinical trial, you’re helping to represent both your community and all people who are affected by advanced breast cancer.

Frequently asked questions

Where can I find more information about this clinical trial?

Details about the study medicine and fulvestrant will be answered during the informed consent process.

Is this helpful?
Will I receive active medicine?

Yes. All participants will receive active medicine. There is no placebo in this clinical trial. (A placebo does not have any medicine in it but looks just like the medicine being studied.) You will have a 50% chance of receiving the study medicine and a 50% chance of receiving fulvestrant (a medicine that is approved in the United States for the treatment of your breast cancer).

Is this helpful?
What are the treatments in this clinical trial and how do they work?

The study medicine, ARV-471 (also known as vepdegestrant), is a type of medicine called a PROTAC protein degrader. It is believed to work by targeting and degrading the estrogen receptor that is found in breast cancer cells. This prevents estrogen from connecting to the cancer cells which may block estrogen’s effects of helping the cancer cells grow.

Fulvestrant is a medicine that is commonly used worldwide for the treatment of breast cancer. You may not have to take part in this trial to receive fulvestrant as it may be available by a doctor’s prescription.

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Will I know if I receive the study medicine or fulvestrant?

This clinical trial is ‘open-label,’ which means that both you and your study doctor will know if you receive the study medicine or fulvestrant.

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How are the clinical trial treatments given?

The study medicine, ARV-471 (also known as vepdegestrant), is taken by mouth with food at approximately the same time each day, preferably in the morning.

Fulvestrant will be administrated as an injection into your muscle and will be given at the research site monthly during regular study visits. However, during the first month of treatment participants will visit the study doctor twice to receive fulvestrant.

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Do I need to provide tumor samples during the clinical trial?

You will be asked to provide a sample of your tumor collected at the time of reappearance of your tumor locally or spread to your body after a period of improvement. If this tumor sample is NOT available, unless the disease has reappeared to bones only, a new biopsy is needed. If you have bone lesions only, you will be asked to provide a tumor sample collected at the time of initial diagnosis.

If you stop treatment because your cancer is getting worse and your study doctor thinks the procedure is safe for you, you can choose to have a biopsy (not required) at the end of your treatment.

The biopsy can be done with a needle or through a minor surgery, and it is usually done with local anesthesia (shots to numb the skin). You may or may not also receive sedation (medicine to help you be calm and comfortable). The study doctor will discuss with you the safest method and location to perform the biopsy.

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How often do you assess my tumor?

Your tumor will be assessed every 8 weeks through approximately the first year, and then every 12 weeks thereafter. This includes scans and measurement of skin lesions. Bone scans will be carried out every 24 weeks, if needed.

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How long do study visits last?

Most study visits last for about 1-2 hours. There are some longer visits which will last about up to 9 hours. You will be given information in advance on which study visits will take longer, so that you can plan your day.

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Will I be reimbursed for clinical trial-related cost?

You may be reimbursed for any reasonable expenses that you may have as a result of taking part in this trial. This may include parking, meals, or other travel-related expenses.

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