ispy2 Trial

crs003

Hello,

I was given the opportunity to participate in the ispy2 drug trial that would put me in a group who receives Taxol plus the investigational drug that is supposed to be very specific to my type of protein/gene type. If I decide to not be in the study, I would get Taxol and Carboplatin. I do want to have a chance to be offered a drug that may be more specific, and to help researchers develop more personalized treatment options, so that is a plus. However, I would lose the opportunity to have Carboplatin, which has shown to have higher rates of complete pathological response when added. Has anyone been in ispy2 trial? What would you do? I am 36, triple negative, stage IIa or b.

JohnSmith

1. After the trial, would you lose the opportunity to use Carboplatin on its own or only when combined with Taxol?
2. What's the new drug?

For those that are curious, the I-SPY 2 represents an unprecedented reengineering of the clinical trial design process. The traditional clinical trial system is old, expensive and painfully slow. I-Spy2 trials have been around for a few years (it's mentioned in a few different forum threads) and offered at ~20 locations around the US, with the lead site at UCSF in San Francisco, CA. Here's a quick glimpse of how ISPY2 works: I-SPY 2 is an Innovative public-private collaboration that combines Personalized Medicine & Novel Trial Design to develop new cancer treatments much faster and for much less cost

crs003

JohnSmith- The protocol is Taxol + investigational drug, or control, Taxol only for 12 wks, followed by AC for 12 wks. It is my understanding that I can withdrawl at any time, or if I am not responding, have my treatment changed, though I don't know how that would affect the study results. I will first go through the screening phase, which includes a biopsy and mri that will match me with the drug, so I don't know what the drug is, but I will be given that information and all of the side effects at that time and decide if I want to continue. It is phase II, so the drug has already been tested in humans.

kayb- You are correct, they were very clear about being able to withdrawl at any time. There have been 45 women enrolled before me, but not all received the same drug. My only concern is that I will miss out on Carboplatin as a first line treatment. They will be monitoring me very closely with mris, but I worry about losing that time. Maybe I need another discussion with my MO to address this concern. My gut is saying go aggressive as possible.

 

crs003

That's a good idea, I have read one study, but it may be good to know if it was significant or replicated. Also the thought of another core biopsy and MRIs sounds exhausting, but it may be good to know my Mammoprint and more info about my tumor.  I will be doing fertility treatment at the same time as the screening phase. Does anyone know if MRI affects egg maturation/harvesting? Thanks for all the advice!

JohnSmith

Some updates from the fabulous I-Spy2 Clinical Trials...
I-SPY 2 Paves the Way for Novel HER2-Targeted Agents in Breast Cancer

1. Neratinib for TNBC.
This tyrosine kinase inhibitor is historically been under investigation for the treatment of HER2+ breast cancer, but is showing benefit for TNBC in the I-Spy2 trials.

2. MK-2206, an AKT inhibitor. When added to trastuzumab (Herceptin), it improved the pathologic complete response rate (pCR)

3. Pembrolizumab (Keytruda), a checkpoint inhibitor which falls under the umbrella of Immunotherapy, is generating durable responses in a variety of cancers. It's being added to HER2-specific kinase inhibitors and generating benefit for HER2+ patients.