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Studies for people with ER-positive, HER2-negative advanced or metastatic breast cancer (VERITAC Studies)

Treatment
Treatment studies for ER-positive, HER2-negative metastatic breast cancer

Study Contact Information:

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

When calling the contact center, please reference the NCT number.


Studies for People With ER-Positive, HER2-Negative Advanced or Metastatic Breast Cancer (VERITAC Studies)

Researchers at Pfizer and Arvinas are conducting the VERITAC-2 and VERITAC-3 studies for people with ER-positive, advanced (locally advanced or ) breast cancer. The studies are looking at the safety of an oral study medicine, ARV-471 (also known as vepdegestrant or PF-07850327), and how well it works either alone or combined with another breast cancer medicine, palbociclib (also known as IBRANCE®).

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

About the studies:

What the Studies Involve

  • VERITAC-2 is a , 2-arm study.
    • Participants will be randomly assigned to receive either ARV-471 or the hormone therapy, fulvestrant.
    • There is a 50% chance of receiving ARV-471 or a 50% chance of receiving fulvestrant.
    • Participants will know which medication they are receiving.
  • VERITAC-3 is a , study.
    • The current part of the study is exploring two different doses of palbociclib (IBRANCE®) in combination with the same dose of ARV-471 and is the lead-in to the Phase 3 part of the study. Researchers want to find which dose of palbociclib is optimal to take with ARV-471 for treating locally advanced or breast cancer.
    • Participants will be to their dose of palbociclib and will know which dose they are taking.
  • There are no (inactive medicine) for groups in these studies that are currently enrolling.
  • If you choose to participate, you will sign the informed consent document and continue with the prescreening (VERITAC-2 only) 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 eligibility criteria for the study.
  • Both studies are researching ARV-471. ARV-471 is taken by mouth with food at approximately the same time each day, preferably in the morning.
    • VERITAC-2: Comparing ARV-471 to fulvestrant
      • For participants receiving fulvestrant, this medication is administered as an injection and will be given at the study site.
    • VERITAC-3: ARV-471 in combination with palbociclib
      • Palbociclib is taken by mouth, with food, at approximately the same time, once per day, preferably in the morning. Palbociclib should be taken with ARV-471.
  • The time you can expect to be in any of these studies 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

  • VERITAC-2:
    • 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.
    • Most of the study visits will last for about 2-3 hours. 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. Most study visits will take place at the site.
    • 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.
  • VERITAC-3:
    • Treatment is broken up into cycles; each cycle last 4 weeks.
    • There are three study visits in Cycle 1, two visits in Cycle 2, and one visit per treatment cycle thereafter.
    • Most study visits will last for about 2-3 hours, although some visits could last for about 6-8 hours. Longer visits are more likely during the first two cycles.
    • 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 for the first three assessments, every 12 weeks thereafter. This includes scans and measurement of skin/superficial lesions, if any. Bone scans will be carried out every 24 weeks, if needed.

Any additional follow ups or steps involved in participation and a timeline

  • VERITAC-2:
    • 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.
  • VERITAC-3:
    • 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).
    • You will be contacted or asked to visit the study site to collect information on the start date of the first anticancer therapy you have received after stopping the study medicines.

Any compensation they may receive for treatment-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

Visit these links for a full list of participating locations. 

Lead Researchers/Study PI's

  • VERITAC-2:
    • Dr. Erika Hamilton, Tennessee Oncology, Nashville, TN
    • Dr. Mario Campone, Institut de Cancérologie de l`Ouest, Saint-Herblain, France
  • VERITAC-3:
    • Dr. Seth Wander, Massachusetts General Hospital, Boston, MA
    • Dr. Michelino De Laurentiis, Istituto Nazionale Tumori, Naples, Italy
This Study is Open To:

People with the following may be eligible: 

VERITAC-2:

  • 18 years old and older
  • Have ER-positive, HER2- negative locoregional recurrent or breast cancer
  • Have received 1 round of treatment that included 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 disease (i.e., disease has spread to other parts of the body)
  • May have received 1 additional round of treatment with hormone therapy
  • The cancer has worsened during or after last therapy

*CDK4/6 inhibitors include medications called Ibrance, which is also called palbociclib, Kisqali, which is also called ribociclib, and Verzenio, which is also called abemaciclib.

VERITAC-3:

  • 18 years old or older
  • Have ER-positive, locally advanced or breast cancer
  • Have not received any prior therapy for locoregionally advanced (cancer that has grown or spread locally, but not found in distant locations of the body) or disease (i.e., disease has spread to other parts of the body)

There are other requirements to join this study. The study doctor will help determine if this study is right for you.

This Study is Not Open To:

People with the following are not eligible: 

  • History of any tumor malignancies other than breast cancer within the past 3 years
  • Have newly diagnosed brain 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

There are other requirements to join this study. The study doctor will help determine if this study is right for you.