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Topic: Phase I Clinical Trial Enrolling People With Advanced HR+, HER2-

Forum: Stage IV/Metastatic Breast Cancer, Open to All To Contribute —

Topics here are started by members with a Stage IV/Metastatic Breast Cancer diagnosis, but open to all members to contribute to discussions. Please note that there is a separate forum, Stage IV/Metastatic Breast Cancer ONLY, where topics are open only to those members.

Posted on: May 14, 2021 12:07PM - edited Jul 31, 2021 03:56PM by Moderators

Moderators wrote:

Boehringer Ingelheim, a sponsor, is seeking participants in the United States for a clinical trial of an experimental breast cancer treatment. The treatment is a combination of xentuzumab (the drug in development) with the targeted therapy Verzenio (chemical name: abemaciclib) and the hormonal therapy Faslodex (chemical name: fulvestrant). Learn more HERE.

Xentuzumab is a targeted therapy that binds to two proteins called insulin-like growth factor 1 (IGF-1) and insulin-like growth factor 2 (IGF-2) and blocks their growth effect on tumoral cells.

This phase I trial is enrolling postmenopausal people (including those with medically induced menopause) diagnosed with locally advanced or metastatic hormone-receptor-positive, HER2-negative breast cancer who meet all of the following main criteria:

  • The cancer has spread to the residual breast, the lymph nodes, bones, or skin
  • The cancer has not spread to the brain, lungs or liver
  • The cancer has grown during or after treatment with a combination of:
    • an aromatase inhibitor: Arimidex (chemical name: anastrozole) or Aromasin (chemical name: exemestane) or Femara (chemical name: letrozole) AND
    • either Ibrance (chemical name: palbociclib) or Kisqali (chemical name: ribociclib)
  • You have not been treated previously with Verzenio
  • You have not been treated previously with chemotherapy for locally advanced or metastatic disease

Clinical trials are done in a series of four steps, or "phases." Phase I trials are small (usually 1 to 50 people), early steps in the process of developing new treatments. The main goal of a phase I trial is to figure out the best way to give a treatment and the highest dose that can be given safely without causing serious side effects. Because this is a phase I trial, and less is known about the study treatment than in later phase trials, it's important to talk with your doctor to make sure taking part in the trial is right for your unique situation.

This study is enrolling people for what's called an "expansion cohort." This means that the researchers have already completed much of the study and have already found a safe dose of the study medicine that everyone will receive moving forward. Researchers want to see if xentuzumab in combination to the 2 other drugs can shrink or stop the growth of your breast cancer disease.

Xentuzumab has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of people with cancer.

Xentuzumab is given intravenously, which means the medicine is delivered directly into your bloodstream every week. Verzenio is a pill taken by mouth every day. Faslodex is given as an injection into a muscle every month.

The most common side effects, generally with an intensity mild or moderate, observed during xentuzumab treatment are:

  • fatigue
  • decreased appetite
  • nausea
  • diarrhea
  • vomiting

The addition of xentuzumab did not add additional toxicity to the side effects we know for Verzenio and Faslodex.

Read more about Verzenio and Faslodex on

For more information on this phase I clinical trial of xentuzumab combined with Verzenio and Faslodex, talk with your doctor and visit:

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