Boo hoo, no longer #2

Yes, it's true. I am no longer #2 in the world when it comes to taking part in a specific drug trial. This new trial has me as one of 1,000 participants worldwide. Turns out there were earlier trials with a small group that proved very successful, so the researchers are trying the same protocol with a wider sample.

Currently waiting for confirmation from Germany (where the study is headquartered) that I can take part. Seems that at the time I was diagnosed with Her2+ breast cancer, some labs around the world were misdiagnosing the factor - something that must be confirmed prior to participating in this drug study as the drugs only work for folks who are Her2+. My team at the BC Cancer Agency is pretty certain I qualify as I've responded so well in the past to treatments designed to address Her2+ cancer. Apparently when I had my surgery back in Nov 2007, some extra tissue was "banked" (am told this is standard practice for any surgery performed in BC). A portion of that tissue has been sent to the lab in Germany for testing and will, thus, form the basis of the confirmation. In the meantime, I'm undergoing more baseline tests in preparation for next week when I'm scheduled to start the study - assuming all goes well at the lab in Germany.

For the medical types out there, the trial is sponsored by Hoffmann La Roche Limited and Genentech. Which might explain why I suddenly have a desire to see a performance based on the tales of Hoffmann (like the opera The Rake's Progress that I saw in New York so many years ago - with amazing sets and costumes by David Hockney). But I digress.

Much of the actual trial particulars will remain unknown until Feb 15 when I next see my oncologist. That is because once my participation in the trial is confirmed, I will be "randomized" (have my name fed into a computer) to see if I will be in Group 1 or 2 of the trial. Let me back up a bit to better explain.

This is a phase III study, the purpose of which is to compare the effects, good and/or bad, of trastuzumab-MCC-DM1 (T-DM1) with Capecitabine plus Lapatinib to find out which treatment is better. I will receive either T-DM1 or Capecitabine plus Lapatinib depending on whether I am in Group 1 or 2. Nobody will receive both. There is no placebo in this study. Group 1 will receive T-DM1, the investigational product. Group 2 will receive Capecitabine plus Lapatinib. The T-DM1 will be administered via IV. The others are all oral medications.

Regardless of which group I'm assigned to, regular tests and exams will be given to monitor my weight, blood pressure, heart rate, and so forth. Blood samples will be collected on a regular basis to check blood counts, liver and kidney function, and blood clotting ability. I'll also receive routine ECHO scans to look for changes in heart function.

Possible side effects for T-DM1 include fatigue, weight loss, nose bleed, upper respiratory tract infection, urinary tract infection, among other things. Less common side effects include such delights as seizures and ataxia. Sepsis and aphasia are rarely reported problems.

Side effects associated with Capecitabine and Lapatinib can include fever, diarrhea, vomiting, fatigue, hand-foot syndrome, eye irritation (also night blindness), anemia, pain in arms/legs/back, difficulty breathing. Dehydration due to bad diarrhea, heart dysfunction, lung problems, and liver inflammation are less common issues also experienced with these drugs.

Despite any of these side effects, it's worth giving the treatment a try. If it fails to work as expected or if I am unable to deal with the side effects, I can always go back to the drug trial that was originally on offer. The reason for trying this one first is two-fold: First, this trial requires that I not have had Lapatinib before. The originally trial had no such requirement. Further, if the treatment I receive from this trial works, I can have it indefinitely whereas the original trial only offered treatment for the six-month duration of that trial. And if neither of those options helps, I might qualify for other trials that are either already on the books or are coming down the pike.

Yes, I am a tad nervous about what lays before me. Reading about nasty potential side effects never sits well. On the other hand, I'm very excited about being able to help advance the treatment of cancer. Better than buying a pink blender, me thinks! In any case, I will just have to be content to wait and see whatever comes my way. With luck, I will continue to feel as well as I do now. And my waistline won't be too upset if I lose a bit of weight - which is one of the most commonly listed side effects of these drugs. Hey, things could be much worse. Besides, the sun is shining and my new sofa arrives today. Woohoo!