Seems straightforward, but it's not as cut and dry when you've already been through chemo and don't really want to revisit that - plus your body is still recovering from the last chemo, surgery, and radiation. Get my drift?
For those of you that want to know the answer up front -- yes, I've decided in favor of participating in the clinical trial. For those of you that want to know more about the trial and my decision to try to participate, keep reading!
What does this decision mean?
It means I'm willingly applying to be a participant in a clinical trial. Just because I'm a BC gal that looks to be a good test subject, I don't have an automatic "in" with the clinical trial. They need to run some screening tests (bloodwork, EKG, possible others) to make sure I'm a good candidate. I also need to make sure my insurance will cover this trial, as the trial does not cover all of the expenses related to participating in this study.
When does it start?
At minimum, I will need 14 days between radiation (which ends on January 19) and the beginning of the clinical trial. I can begin as late as 84 days post-radiation; however, I'm of the mind to get it started sooner so I can enjoy this summer! I'm tentatively scheduled to meet with the head of this clinical trial during the first week of February. At that time, I'll have screening tests done, sign the consent form in person, and ask any additional questions I have about the trial. It could begin as soon as the test results are in and I'm cleared to participate.
What phase is this trial?
This clinical trial is a randomized Phase II study. A Phase II trial is defined as: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.
What the study will entail:
I will be randomized into 1 of 2 groups after my screening tests are complete. The two groups are:
Group A: Cisplatin through a 60 minute IV on Day 1, to be repeated every 21 days for a total of 4 treatments (12 weeks total)
Group B: Cisplatin through a 60 minute IV on Day 1, to be repeated every 21 days for a total of 4 treatments (12 weeks total) + Receive study drug (PARP inhibitor) on days 1, 2, and 3 to be repeated every 21 days for a total of 4 treatments + After 4 treatments, go on a maintenance treatment of just PARP inhibitor taken by mouth once a week for a total of 24 weeksAfter the trial, they will monitor my health through an end of treatment visit 1-2 months from my last treatment. And via follow-up appointments (done every 4 months for years 1 and 2 and every 6 months for years 3-5).
How did I make this decision?
With the help of my medical care providers, my family (they asked questions and researched with me), friends (bouncing ideas/concerns off of them), and by asking myself if I could live with a clear conscience if I didn't do the study. The benefits are at least two-fold:
1. No matter the arm of the study, I'm receiving Cisplatin - a drug that's proven to be effective in metastatic breast cancer cases. It should seek and destroy cancer cells if any remain in me.
2. The results from this trial will be used to help other breast cancer survivors.
I don't necessarily want do it, but realize the value in receiving Cisplatin at this point (and therefore a need to participate). I want to come to the cancer-fighting table with "guns blazing" and this trial offers me the chance to do one more thing to kick some cancer cell ass. (Remind me of the reasoning for this decision if I get grumpy about the study, please.)
2 comments:
Laura, thanks for the update. I'm so glad you have been able to come to a decision on this. I'm sure it's a relief. It sounds like you've really thought this through. Let us know how the meeting goes. I hope this next phase of the journey leads to many good things. Hugs, Amber
Thanks for your comment, Amber. I'm glad I had a decent amount of time to ruminate on this decision. I, too, hope it leads to good things...as in NO MORE CANCER! :)
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