A clinical trial for people with ER-positive, HER2-negative advanced (locally advanced or metastatic) breast cancer: VERITAC-2

Clinicaltrials.gov identifier:
NCT05654623 (https://clinicaltrials.gov/show/NCT05654623)

Treatment
A clinical trial for ER-positive, HER2-negative advanced breast cancer

Pfizer Clinical Trial Contact Center by phone 1-800-887-7002 or email [email protected]

When calling or emailing the contact center, please reference the NCT number, NCT05654623.

About the VERITAC-2 Clinical Trial

Researchers at Pfizer and Arvinas are conducting the VERITAC-2 clinical trial for people with ER-positive, HER2-negative advanced (locally advanced or metastatic) breast cancer that has progressed after previous treatment. This clinical trial is specifically for people who have already been treated with CDK4/6 inhibitor* therapy in combination with hormone therapy for their locoregional recurrent/metastatic disease.

VERITAC-2 is looking at the safety of an oral study medicine, ARV-471 (also known as vepdegestrant), and how well it works when given alone as compared to fulvestrant.

ARV-471 is believed to work by targeting and breaking down the estrogen receptor that is found in breast cancer cells. This prevents estrogen from connecting to the cancer cells, which may block estrogen’s effect on cancer cell growth.

For more information, visit, www.veritac2study.com

* CDK4/6 inhibitors include medications called palbociclib (IBRANCE®), ribociclib (KISQALI®), and abemaciclib (Verzenio®).

What the VERITAC-2 Clinical Trial Involves:

VERITAC-2 is a randomized, open-label 2-arm clinical trial.
Participants will be randomly assigned to receive either ARV-471 or the hormone therapy, fulvestrant. There is a 50% chance of receiving ARV-471 and a 50% chance of receiving fulvestrant. There is no placebo (inactive medicine) for group in this clinical trial. Participants will know which medication they are receiving.
ARV-471 is taken by mouth with food at approximately the same time each day, preferably in the morning. Fulvestrant is administered as an injection and will be given at the study site.
If you choose to participate, you will sign the informed consent document and continue with the prescreening and screening periods. Tests such as a physical exam, electrocardiogram, CT/MRI/Xray scans, and blood sample collections will be performed to confirm if you meet all the participation criteria for the study.
The time you can expect to be in this study depends upon a few things, including how you tolerate the medicine(s), how your cancer responds, and your personal choice.

Any additional screening, biopsies, appointments, monitoring

During the treatment period, participants will visit the study site every 4 weeks. Participants receiving fulvestrant will have one additional visit in the first month.
Many study visits will include a physical examination, blood draws, a discussion of how you are feeling, and other assessments and activities. 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/superficial lesions, if any. Bone scans will be done every 24 weeks, if needed.
Most of the study visits will last for about 2-3 hours and will take place at the study site. However, if you are in the ARV-471 group, some study visits may take up to about 9 hours. Longer visits are more likely during the first three cycles.

Any additional follow-ups or steps involved in participation

After the treatment period, there is an end-of-treatment visit and a safety follow-up visit about one month after completing the end of treatment visit (or earlier if you start new anticancer therapy).
Afterwards, participants enter the follow-up period in which they will be contacted every three months until the study ends. You may also be asked to visit the study site so the study doctor can monitor your breast cancer.

Any compensation they may receive for clinical trial-related costs

The study medicine and any study-related procedures are generally covered at no cost.
Participants may be reimbursed for any reasonable study-related expenses. This may include parking, meals, or other travel-related expenses.

Study Locations

To view the list of enrolling study sites, visit www.veritac2study.com

Lead Researchers/Study PI's and Affiliation:

Dr. Erika Hamilton, Tennessee Oncology, Nashville, TN
Dr. Mario Campone, Institut de Cancérologie de l`Ouest, Saint-Herblain, France

This Study is Open To:

People with the following may be eligible:

18 years old and older
Have ER-positive, HER2-negative locoregional recurrent or metastatic breast cancer
Must have been treated with a CDK4/6 inhibitor* therapy, in combination with hormone therapy, for locoregional recurrent disease (i.e., the disease comes back in the place where it started or in the nearby region) or for metastatic disease (i.e., disease has spread to other parts of the body).
May have received 1 additional round of treatment with hormone therapy
Cancer has worsened during or after your last therapy