Someone in my Paxman Facebook group mentioned Signatera to monitor for possible recurrence in early breast cancer. Does anyone use this blood test? Is it effective? Or another liquid biopsy test?
missbashful, The accuracy/usefulness of Signatera in breast cancer has yet to be shown so it is not standard of care. There is a phase 2 clinical trial to investigate this underway but of course, like all clinical trials, there are very strict requirements for participation.
If you fit the profile you might want to consider applying.
Beyond the accuracy of the blood test being in question there is also an issue with knowing what to do with the information. If you have a positive blood test but no symptoms insurance will not approve a scan. Furthermore, no treatment at this time is recommended so oncologists don't have a game plan either.
I’m using the test. My Dr ordered it. As mentioned above, there is currently no standard of care if you test positive. Based on my study of the clinical studies, I believe it is highly sensitive for positive results. There is a study called DARE https://clinicaltrials.gov/ct2/show/NCT04567420that randomizes patients with positive results into a groups where one gets palbociclib and fulvestrant and the other gets “standard of care” which is watch and wait. You don’t have to be monitored in the trial to get randomized if you are positive
Because my Dr ordered the test and insurance declined to pay, Natera worked with the insurers for a very low contract rate, and at this time, they are not billing me the balance. I believe that eventually this technology is going to yield important changes in surveillance and has the potential to allow treatment before mets are visible on imaging. I hope it’s going to be akin to the horse being out of the barn, but still being on a halter in the paddock rather than running free on the range. For high risk tumors, I think asking your doctor to order the test is certainly worth it. And I was personally thrilled that my first test was negative. There is a study that in lung cancer, 18 months of negative molecular residual disease results (what Signatera tests) has positive indication for long term remission. It’s just a blood test, and I had my follow up today where they just filled 3 more tubes with the same needle stick and my regular appointment.
saramaude, It's great that your doctor ordered the Signatera and you are getting coverage for the cost. I almost fit the profile for the clinical trial but I have interstitial lung disease which precludes me from the palbociclib arm. I volunteered to be in the standard of care arm but, of course, they told me no go since it wouldn't be random. I love your analogy of catching the horse in the paddock before he is loose on the range. I think that this test will provide some peace of mind or lengthen survival with earlier treatment. Hopefully the clinical trial will have good results and proceed to phase 3 quickly.
Maggie, in the Signatera Phase 2 trial do they put those who test positive on a medication? If yes, what kind?
Muska, those who test positive are randomized to two arms. One group gets palbociclib plus fulvestrant while the other group gets standard of care, i.e. continue with their current endocrine therapy.
I have a Signatera blood collection kit sitting on my desk, and the tumor sample delivery to Natera (Signatera's manufacturer) has been already discussed and confirmed with the lab that will be analyzing my tumor after my DMX in Feb. I am not in any clinical trial. The idea came from my husband, who's a clinical geneticist, knows about these things, and a fun fact even interviewed with Natera some years ago lol. He contacted Natera, they had no problem with his request and sent us the blood collection kit. One box on its paperwork will have to be filled in by my breast surgeon; we had explained to her that we'd like to have Signatera run immediately after my surgery and then bloodwork repeated annually for monitoring purposes. If my insurance refuses to cover it, I will pay out of pocket. With two small kids, I feel the expense is justified.
I am not in a trial either, by the way. My doctor just ordered testing through Natera. If your doctor orders the testing, the company is being very flexible with payment. I think they are trying to collect a good data set to show the value of the testing. Personally, it gave me more peace of mind than the CT scan. I work in technology, and I think it's the best diagnostic innovation lately for sure.
I second what anniepnw and sarahmaude have to say. My husband is a retired clinical/population geneticist and he thinks the evidence for using Signatera is very strong: FDA and medicare approval for colon cancer, good early results in clinical trials for other cancers and basic biology. Unfortunately my pulmonologist has recommended that I do not pursue this since most treatments for mbc would cause more harm than good given my ILD. Otherwise, I would definitely be on board.
I talked to Natera's patient coordinator today about logistics for sample delivery. They do run the whole genome on both the blood and tumor samples which is very nice. A few links that might be helpful for someone who's interested: