NCT05654623

The VERITAC-2 study will help us learn if an investigational medication (ARV-471) works better than fulvestrant (comparator medicine) in prolonging the time without disease worsening in people with advanced breast cancer. Pfizer and Arvinas Estrogen Receptor, Inc. have partnered to co-develop the investigational medication.

Hormonal therapy (sometimes called endocrine therapy) is the standard of care for people with ER-positive advanced breast cancer. However, some people may stop responding after or during hormonal therapy.

All participants in this study will receive the investigational medicine (ARV-471) or fulvestrant (the comparator medicine) which is an established standard of care that is currently used in people with advanced breast cancer.

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Who may participate

Thank you for considering the VERITAC-2 study. Joining a clinical trial is an important and personal decision. By volunteering in clinical research, you can make a difference.

The VERITAC-2 study is enrolling people aged 18 years old or older with advanced breast cancer.

If you think this study could be right for you, use the Get Started link to answer a few questions.

Condition

ER-positive, HER2-negative advanced breast cancer

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Age

18+ years

The age a person must be to participate in a clinical trial.

Sex

Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Each clinical study 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 study.

Get started — See if you may qualify

A first step as you consider participating in these studies is to answer a 5-minute online questionnaire about your health and medical history. Please answer the questions to the best of your ability and to the extent you feel comfortable. You can skip questions, however, providing more information will help our clinical trial finder, a secure system powered by Leal Health, to see if you may be eligible for a study based on your health and medical history..

By entering your information into the online questionnaire, you are creating an account and profile with Leal Health which will allow you to see if you may be eligible for any breast cancer studies. At the end of the online questionnaire, you will be able to see how many studies you may potentially qualify for.

By providing your contact information, you are providing permission for a member of the Leal Health Patient Support Team to contact you and discuss next steps. They will be available to help you navigate the process of finding a study, answering your questions, and helping you prepare to talk with your oncologist.

If you would like to be referred to a nearby clinic, your Patient Support Team Member will ask you to provide written permission for Leal Health to share your contact information with the study team at the clinic who will then contact you and will likely ask you to come in for an appointment. Only the study team can determine if you meet all the study’s eligibility criteria and are able to enroll in the study.

If it appears that you may be eligible to participate in a Pfizer breast cancer study after completing the online questionnaire, you will see the list of potential Pfizer sponsored studies first. If there are no Pfizer sponsored studies in the list, you can provide permission for Leal Health to continue searching for an appropriate study sponsored by another organization.

We encourage you to review Leal Health’s privacy policy (linked below) before you complete the online questionnaire. Your answers including any personal information will be kept confidential by Leal Health throughout the prescreening process.

Your answers to the online questionnaire will only be linked to you if your responses indicate that you may be eligible to participate in a study and you choose to share your contact information with that study team. Pfizer study team members and our partners will have access to reports containing aggregated (combined) data that will not be directly linked back to you.

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What to expect

The study team will answer any questions you may have. If you choose to participate, you will sign the informed consent document and continue with the pre-screening period. During the pre-screening period, you will be asked to provide blood samples for your estrogen receptor (ESR1) status evaluation.

After getting these results, the study team will perform some tests to further confirm whether you meet all the eligibility criteria and are able to participate. You will be randomly assigned to a treatment group. You will either receive the investigational medication (ARV-471,) or fulvestrant.

You will have a 50% chance of receiving the investigational medication and a 50% chance of receiving fulvestrant

Length of study treatment

You may be in the study for up to 3 years.

Length of study treatment is the length of time the study participants will receive the study treatment.

Number of study visits

Once every 4 weeks until treatment discontinuation.

Each clinical trial’s design specifies the number of study visits and the total length of the trial.

Long-term follow up

You will be contacted every 3 months.

Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the main part of the study. This long-term follow up is to collect additional information on the study drug over time.

About ER-positive, HER2-negative advanced breast cancer

About ER-positive, HER2-negative advanced breast cancer

About 80% of all breast cancers are “ER-positive”, which means that the breast cancer cells have receptors on the outside of their walls that can catch specific hormones in your body. ER-positive cancer cells grow in response to the hormone estrogen; therefore, hormone therapies are likely to work well in this type of breast cancer.

HER2 (human epidermal growth factor receptor 2) proteins are a type of cell surface protein that are involved in normal cell growth. If breast cancer cells don’t have abnormal levels of HER2 proteins, the breast cancer is considered HER2-negative.

Frequently asked questions

Will I receive active medicine?

Yes. There is no placebo (inactive medicine) in this study, and all participants will receive active medicine. You will have a 50% chance of receiving the investigational medication ARV-471 and a 50% chance of receiving fulvestrant (a drug that is approved in most of the countries for the treatment of your breast cancer).

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How are the study treatments given?

The investigational medication (ARV-471) will be taken by mouth at home on days in which you are not seen at the research site. You need to take the investigational medication (ARV-471) at the same time in the morning with food. Fulvestrant will be administrated as an injection into your muscle and will be given at the research site.

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Do I need to provide tumor samples during the study?

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 (drugs 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.

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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 visit will take longer, so that you can plan your day.

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Will I get be reimbursed for study-related cost?

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