There is a breast cancer trial that is recruiting right now for a new targeted therapy. You may be eligible to participate or you may know someone who is eligible. We all benefit from this so I’m asking this be shared in as many places as possible, especially in groups where there is a large population of people with advanced or metastatic breast cancer.
Afraid of participating in a clinical trial. Worried about that lab rat thing? Please click over to this post for a basic rundown. I’ll just say this. When anything other than cells in a dish are involved, protection of humans and animals is taken quite seriously. There are rules in place for the real rats. Seriously.
Do you fit the profile for this trial? Here’s the checklist:
- Are you post-menopausal? It doesn’t matter if it happened naturally, surgically or through ovarian suppression.
- Has your cancer spread outside of your breast?
- Is your cancer ER+ or PR+ (either one will do)?
- HER2 negative?
- Have you done only one line of endocrine treatment since the disease metastasized? In English, did you take tamoxifen or femara or arimidex and only one!
All yes responses to that group? Let’s continue. (Yes responses to these questions will likely result in being ineligible.)
- Have you been treated with chemotherapy since your metastasis? If so, you may not be eligible but definitely check with the researchers.
- Have you already been treated with fulvestrant (Faslodex) or everolimus (Afinitor)? If so, unfortunately, you will not be eligible for this particular trial.
- Has your cancer spread to your central nervous system (i.e. brain mets)?
- Do you have inflammatory breast cancer?
- Inflammatory breast cancer patients or those whose disease has metastasized to the central nervous system, this trial isn’t for you. We’ll find others.
There are obviously many other items that will determine inclusion/exclusion but those are the ones that jumped off the page for me.
A little about the trial and what to expect:
- The length of time for participation is 36 weeks.
- You will need to be at the test site for approximately 15 visits. This is a multi-center trial. A list of locations is included in the eligibility link below.
- In the beginning the visits will be frequent and then taper off.
- There is no cost to you to obtain the drug or any of the testing.
- Travel may be reimbursed.
- You will be randomly assigned to receive the real medication or a placebo.
- All participants will be treated with fulvestrant which is currently one of the standards of care for metastatic disease. My mom is already on fulvestrant but was ready to step right up until I told her she wasn’t eligible.
- The purpose of this trial is to determine if combination therapy of the fulvestrant and the investigational drug is better than fulvestrant alone.
- THIS IS THE MOST IMPORTANT PART OF THE POST: You can read more about the study on Trial Reach where there is a link to the complete study information on clinicaltrials.gov.
Why do this? You may be helping yourself. And who knows, this might be the next big thing and you may be part of something that help us finally turn a corner. I’ve participated in a number of trials and I wouldn’t hesitate to join another. I hope you feel the same way. Without us, there will be no advances. Having a trial not meet accrual goals in an expeditious fashion is a waste of precious resources. Closing promising trials because goals are not met is a story for another day. But, it does, indeed happen. And the reason?
Primarily because we simply don’t know we are needed.
Now, you know.
Please do share this! It’s important. Lives depend on it.