What is the SOPHIA study?

The SOPHIA study is a research study that is currently evaluating the safety and effectiveness of a new investigational medication for the treatment of HER2‑positive metastatic breast cancer (MBC). It is a study designed to evaluate new treatment possibilities to support those with the unique diagnosis of HER2‑positive MBC.

If you have previously received treatment for metastatic HER2‑positive breast cancer, you may be eligible to participate in the SOPHIA study.

Frequently Asked Questions

What is a clinical trial?

Clinical research trials are medical or health-related research studies in which participants help test the safety and effectiveness of an investigational medication. These studies follow a strict protocol – a written plan of actions.

What is an investigational medication?

An investigational medication is a drug unapproved for marketing by the US Food and Drug Administration (FDA) or other global government offices. It is generally available only for use in clinical research trials to determine its safety and effectiveness.

How does a clinical research trial evaluating an investigational medication work?

Your health history and current status will be checked at the beginning of the trial. If you are eligible, you’ll receive instructions for what you will need to do. You will be monitored carefully throughout the trial by the study team (doctor and staff).

How will my rights and medical safety as a study participant be protected during the clinical trial?

Clinical trials must follow strict ethical and legal standards. In addition, the US federal government and other global health authorities regulate clinical research to protect participants.

Can I leave the clinical trial before it is complete?

Yes. You can withdraw from the trial at any time. If you withdraw, you will be asked to notify the study team, give your reasons for leaving, and follow through with the clinical trial exit process.

Can I still see my regular doctor during the clinical trial period?

Yes. You can still continue your regular visits with your doctor. You or the study team can notify your regular doctor of your participation in the trial.

What if I am interested in learning more about the study medication?

The study team will give you additional information about the study on the consent form. They will also explain potential side effects, risks, and potential benefits of participating in the study.

Why is HER2-positive MBC different?

MBC is an advanced breast cancer that has spread beyond the breast. MBC reaches beyond the breast and lymph nodes under the arm and has spread to other organs in the body, such as the bones, liver, lungs, and brain.

HER2 is a protein that promotes cell growth.
If HER2 is expressed at higher than normal levels, it causes breast cells to grow and divide uncontrollably. HER2‑positive MBC tends to grow faster and is more likely to spread and come back. About one in five breast cancers are HER2‑positive. Although it may be incurable, it may be treatable.

Having HER2‑positive MBC may feel difficult to treat, but there are approaches you can try. The SOPHIA study is here for distinctive patients like you to help evaluate new treatment possibilities in cancer therapy.

Qualified participants will receive:

Thank you for visiting the SOPHIA study website.
For more information on clinical trials and to see a complete list of study sites, click here.