This page is intended for U.S. residents only. The information provided is for information purposes only and is not intended to replace discussions with a healthcare provider. Other sources outside this website are availble for more clinical trials.
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.
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
Age
18+ Years
Sex
Male or Female
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.
Criteria A
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Criteria B
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Criteria C
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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.
Length of study treatment
You may be in the study 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
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).
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.
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.
