EGOG 5103

Because I was young (under 50) and in good health, I have the opportunity to become part of a clinical trial. It is called ECOG 5103.

It is a Double-Blind study (which means neither you or your doctor know which group you are) that adds the drug Avastin to my chemo regiment. Avastin (Bevacizumab) is an IV drug that has been known to help lower the chance of recurrence of cancer in metastatic cancers (secondary cancers). The study is trying to find out if young breast cancer patients will have a lower recurrent rate for a longer period of time. It makes sense... All the studies thus far have been on older women and they don't really need to have THAT long of remission years. But since I'm only 35, I will be 40 when I am completely through with the hormone therapy treatment I still have 30-40 good years left in my for the cancer to come back.

The differences are...

During my first 4 sessions (8 weeks) it is exactly the same, they will just add the extra drug into my IV dose. During the second drug, I will have to go every week, instead of every other week for 12 weeks (instead of the original 8 weeks). At the end of my sessions, I will be unblinded and we will see which group I'm in. Here are the groups:

1. You receive the placebo only (no drugs).


2. You get the drug.


3. You get the drug and an opportunity to stay on the drug for an additional 33 weeks, which equals 1 year).

So now I am completely conflicted. A apart of my wants to say, "HELL NO!! I just want to get through this!" But the other part of me is thinking that every woman given the opportunity said no, then we wouldn't have the life-saving drugs we have now. So after reading about the trial I made a list of my pros and cons.

PROS

• If it works (and I am not on the placebo) it could maybe lower my chances of my cancer returning.
• I could potentially help another woman in my situation in the future.
• The actual drug, Avastin, would be free. I would still pay for the original chemo drugs.

CONS

• Having to go every week for 4-5 hours to get the second round of chemo drugs, which could cause work-related issues.
• Potentially not have enough time between the 2 sessions for my white blood cells to go back up and any better.
• Side effects of just the Avastin: High blood pressure (which is prevalent all through my Mom's family), Hypertensive, Abnormal levels of protein in kidney (could cause liver damage), nose bleeds, sores in mouth and/or throat, skin changes (dryness, itching, discoloration, ulcers), watery eyes. And those are just the "highly likely" side effects. The "less likely" side effects would be blood clots, strokes or heart attacks.
• The Avastin would be paid for, any drugs that I received to help with the side effects would not, and my insurance may not pay for it because it is a clinical trial and not yet approved by the FDA for my condition.
• If while during my treatment (a full year) on Avastin, if the FDA does approve it for my condition, I would probably have to start paying for it for the remainder of the treatment.
• Since it is an IV drug, I would have to return every 3 weeks for a year to keep receiving the treatment, which means keeping the port in that long too.
• Can decrease fertility, or make a woman infertile.

So, after heavy deliberation, I decided NOT to be a part of the study. A part of me still feels bad, like I am letting the woman of the future down (who could God-forbid be one or both of my daughters). But with so many side effects, and having the predisposition for high blood pressure, I don't want to have a stroke or heart attack and leave my children without a mother. I want to help other woman, but not at the extend of my children. It may sound selfish, but I want them to grow up with a mother, and right now the original chemo schedule with do just that. So I called Dr. K and let her know that I would NOT be participating in ECOG 5103.