My mom just received the news that her breast cancer has spread to her lungs and liver. The standard chemo did not kill all the cells. She is now Stage IV metastatic breast cancer. It is inoperable at this point. So, now her doctors want her to participate in a clinical trial for Sutent. I’ve been to many sites about clinical trials. What I’m asking for here is personal experience (either yourself, a friend, or loved one) with clinical trials, specifically for cancer treatment.
Thanks in advance.
Best Answer: Inverse, not completely correct,. Clinical trials do still have a placebo in some cases, and it is ethical because there is not proof the study drug will be better than placebo. Most clinical trials do not though have a placebo ONLY arm.Phase III trials are generally randomized, controlled trials comparing the top contender with the current champion. All patients get treatment, some may get something extra, or may get something completely different ( e.g., A vs B or maybe A + B vs A). The point is to see if the contender is better, in which case it will become "champion", otherwise the champion continues reign.Phase II trials are not usually randomized, and patients generally know going in what they will get. In a phase III study, a computer determines which arm of the treatment you will get; that is OK because the researchers have pre-determined that each of the arms are equivalent to the best of our knowledge currently-- they are trying to see whether that assumption is correct or not.Phase I trials are quite experimental. Patient access is limited, and here mostly what is being accomplished is determining the dose and side effects/tolerance.If your mother is newly diagnosed as stage IV, she should not be on a phase I trial. II or III are reasonable, and III would be preferred. Sutent is an exciting new agent, but she has numerous options, both on trial and standard off-trial options. She needs to fully explore her options with her oncologist and go with the one she is most comfortable with based on prospects for response, toxicity, convenience, etc.God bless. best wishes
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I was recently diagnosed. Before I got the diagnosis, I had decided that if it was Stage IV, I would enroll in clinical trials.
Something you have to understand about cancer clinical trials … there is no placebo … the treatment must have been shown to be effective, because it is considered cruel to not provide effective treatment to a cancer patient. So all cancer trials compare Treatment A to Treatment B.
Inverse, not completely correct,. Clinical trials do still have a placebo in some cases, and it is ethical because there is not proof the study drug will be better than placebo. Most clinical trials do not though have a placebo ONLY arm.
Phase III trials are generally randomized, controlled trials comparing the top contender with the current champion. All patients get treatment, some may get something extra, or may get something completely different ( e.g., A vs B or maybe A + B vs A). The point is to see if the contender is better, in which case it will become “champion”, otherwise the champion continues reign.
Phase II trials are not usually randomized, and patients generally know going in what they will get. In a phase III study, a computer determines which arm of the treatment you will get; that is OK because the researchers have pre-determined that each of the arms are equivalent to the best of our knowledge currently– they are trying to see whether that assumption is correct or not.
Phase I trials are quite experimental. Patient access is limited, and here mostly what is being accomplished is determining the dose and side effects/tolerance.
If your mother is newly diagnosed as stage IV, she should not be on a phase I trial. II or III are reasonable, and III would be preferred. Sutent is an exciting new agent, but she has numerous options, both on trial and standard off-trial options. She needs to fully explore her options with her oncologist and go with the one she is most comfortable with based on prospects for response, toxicity, convenience, etc.
God bless. best wishes