Support Registry Update

About the I-SPY TRIAL

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Elyse Goldberg-Beltran
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Hi family and friends,

I wanted to share more about the experimental research trial I'm part of for my treatment: the I-SPY TRIAL. If I had to get a cancer (which I shouldn't have...), at least I got the one my aunt has spent her life working on through research like this trial, which she developed about 20 years ago. And of course my mom spent her entire career on this disease as well, so I basically have not had to think about a thing. In this sense, the process (so far) been much easier for me than infertility and surrogacy.

Since I have been randomized to the experimental immunotherapy drug in the trial, we are learning as we go. (It's important to note that my aunt had no say whatsoever in what treatment I got randomized to as part of the trial.) So, I'm a bit of a guinea pig, which can be scary at times, but my aunt has said that if there is anyone's whose tumor would respond well to this new drug, it would be someone with a tumor profile like mine.

Here's hoping.

<3 E

Here are some excerpts from the Β I-SPY TRIAL patient-facing website:Β 

  • The I-SPY 2 Trial is an investigational drug trial for newly diagnosed patients with locally advanced breast cancer. An investigational drug has been approved for testing in people by the U.S. Food and Drug Administration (FDA) but has not yet been approved for widespread use. A clinical trial tests how well investigational drugs work and whether they are safe to use.

  • The I-SPY 2 Trial treats newly diagnosed breast cancer with neoadjuvant drug therapy. This means that drug therapy is given before surgery. Neoadjuvant therapy has advantages and disadvantages. One advantage is that it may shrink your tumor, allowing you to have a smaller surgery. One disadvantage is that you have to wait until you have finished neoadjuvant therapy to have your surgery, which may be stressful for some people. However, it is just as safe and effective to have therapy before surgery as after surgery.

  • The I-SPY 2 Trial is testing new investigational drugs and combinations of drugs to find out whether they are better, worse or no different than the standard treatment. Most patients on the trial receive an investigational drug or drug combination that would not be available to them as standard treatment.

  • The I-SPY 2 Trial uses 3D MRIs to monitor your tumor. MRI (Magnetic Resonance Imaging) scans provide you and your care team with detailed pictures of your tumor. Your doctor can see if your tumor is responding to the drugs or not.

  • The I-SPY 2 Trial measures biomarkers (characteristics of your tumor) to learn as much as possible about your breast cancer and how it responds to treatment. A small part of your tumor will be collected by biopsy. Part of this biopsy will be used for molecular testing. These tests may give you and your doctor more information about your tumor, which will help with planning your treatment. As you learned in the videos above, I-SPY 2 is using a new biomarker called the Response Predictive Subtype (RPS). RPS helps predict if your tumor may respond to immune oncology drugs or other types of drugs, such as PARP inhibitors. (Use the NIH Dictionary of Cancer Terms at the bottom of the page to learn more about PARP inhibitors). This also enables you to have a greater chance of being treated with a drug that is targeted to your tumor’s biology.




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