Take part in a clinical trial exploring whether adding a drug called ipatasertib to standard treatment can improve people’s response to breast cancer treatment. The study's title is 'FAIM – Phase II study'.
What’s the study about?
Certain people with secondary ER-positive and HER2-negative breast cancer people don't respond well to standard treatment, however it can be difficult to tell who these people are early on treatment. This clinical trial is studying the addition of ipatasertib in patients who show signs that they may not be responding well to the standard treatments for advanced ER-positive and HER2-negative breast cancer.
The researchers will use a blood test called ctDNA (circulating tumour DNA) to test how well participants are responding to their cancer treatment. The blood test will be carried out before paticipants start standard treatment, and after 2 weeks of treatment. The researchers hope that by picking up signs of the cancer not responding to treatment, they can more effectively treat the cancer by adding the trial drug ipatasertib.
If this trial is successful, it will demonstrate the usefulness of both the ctDNA blood test and ipatasertib for breast cancer patients.
Who can take part?
You can take part if you have secondary breast cancer that is ER-positive and HER2-negative. You must also be eligible for fulvestrant in combination with CDK4/6 inhibitors.
Visit the webpage to view the full criteria for taking part in this study. You can also view the different locations that trial is running at.
Why do you want me to be involved?
This research is important because it could change how we monitor and treat patients with breast cancer in the future.
If you enter the randomised trial, then you may receive ipatasertib in addition to the standard treatments for your breast cancer. This research will help the researchers understand if ipatasertib is an effective treatment for breast cancer.
This study will also help researchers demonstrate if ctDNA blood tests are useful for measuring treatment response. Testing these blood tests further may be valuable in the future for monitoring other cancers as well.
What will you ask me to do?
You’ll first be treated with CDK4/6 inhibitors and fulvestrant.
Blood samples for the tumour DNA blood test will be taken on the first day of treatment and 2 weeks later.
If the blood test shows that you’re responding well to the treatment, you’ll continue the same treatment. If the blood test shows that you may not be responding to treatment well, you may receive ipatasertib in addition to the original treatment.
You’ll then continue to have monthly blood tests. If you respond well to the standard treatment you’ll continue with blood tests every 6 months.
You'll need to travel to in person appointments for tests, and for all treatments if the blood test detects a cancer recurrence in the future. So travel time should be considered if you wish to be referred to another hospital.
How do I get involved?
If your local cancer centre is participating in the FAIM study, you may be referred to a specialist research team for further screening tests to confirm if you can participate. If your local cancer centre is not currently participating, you may be referred to another hospital for further screening tests to confirm if you can participate in FAIM.
Please contact your oncology specialist or surgeon to confirm if you could be eligible for the study. They can arrange for referral to a centre currently running the study.
Please don't contact the FAIM trial team as they're not medically trained to assess your eligibility for the study.
You can also find more information on the project website.
When’s the deadline?
There is no current deadline for this survey. It's ongoing.
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