Are you currently (or have you been) in a Clinical Trial?
Comments
-
pnw,
I'm on my fourth trial (Ibrance, Piqray, Trodelvy, ARX-788) and the documentation, scan frequency, etc. required are all similar to what you described for ARV-471. I haven't any problems with my insurance paying for the extra scans and tests. Insurance doesn't have to pay for the drug so I think they come out ahead. In any case, that's what insurance is for!
One of the benefits of being on a trial is that they assign a trial coordinator to schedule everything for you and you get priority in scheduling. The main reason, for me, is to get early access to great new treatments. At this point, I'm down to old-school chemos or Phase I trials. Every trial I've been on has worked well and the first three were all eventually approved.
Looks like you are in the early stages of your MBC diagnosis so trials may not make sense for you. But keep in mind that a lot of trials exclude patients with prior chemo treatments (including ADCs) so you can plan ahead.
Hugs, Susan
0 -
PNW,
Like Susan, I've been on 4 drug trials & they almost all have these crazy tests which take days of waiting around. The one I'm on right now req'd blood tests every hour for 14 hours the first 2 days. Because I'm in Canada I don't have the insurance issues but it does take a lot out of you. I have been able get access to drugs that I wouldn't have been able to get otherwise. I was on the Ibrance trial which worked for me for 30 months & it was my second or third line which isn't allowed here, first line only.
I've done trials throughout the 8 years that I've had mets. If a line fails me, my MO looks for a trial to extend the number of lines which will be available to me. good luck
0 -
Like Husband, my wife is also taking 9 mg of Enobosarm daily. I too am not convinced it has done much to reduce the disease ,as her tumor markers continue to rise; however, she has had no side effects and she feels pretty darn awesome on it.
I can also say with certainty that VERU (the company trying to bring enobosarm to market) is not shutting down. In fact, they have a microtubule inhibitor they are also studying for breast cancer. The recruitment for that study seems to be on pause...but only because that same drug just had a phase 3 trial for severe covid end early at the request of an independent panel...as it was working too well compared to treatment as usual. It seemingly worked so well, the FDA has suggested they file for an emergency use authorization to bring to market quickly. I suspect as a small company...most of theeir manpower has been diverted to this.
0 -
I am on ARV-471. It isn't working for me. I am on the hunt for something new.
A word about trial protocols: Yeah, they are a pain in the ass. But, I was on a trial drug (H3B-6545) for 15 months with virtually no side affects. I was literally hiking 30 miles a week. The first month or two you feel like you are constantly at the doctors (CTs, MRIs, blood work, EKGs... omg it is a full time job) but you get to a point where you might be on a drug that really works for you, has a slim side effect profile, and you only go in like once a month. Those 15 months were totally worth it for me. I got to live without thinking about cancer. I just want to find another drug like that.
I will do anything for another working trial drug over more chemo.
0 -
Mika, It's very impressive you can navigate from one trial to another- sounds like it'd be good to move off of endocrine therapy for a bit. How about the TREM2-immunotherapy trial?
PY314 (TREM-2) Antibody, alone or with KeytrudaPhase 1a/b. Completes: 10/28/2023 - Mayo Clinic Scottsdale https://www.sciencedaily.com/releases/2020/08/2008... https://clinicaltrials.gov/ct2/show/NCT04691375
Or one with a PARP inhibitor? TALALVE: Talazoparib with Avelumab Completion: Dec 31 2022 Salt Lake City https://clinicaltrials.gov/ct2/show/NCT03964532 No prior PARPi or Immunotherapy
Or the Rosenberg trial: https://www.clinicaltrials.gov/ct2/show/NCT01174121
0 -
Thank you cure-ious. I will definitely take those back to my oncologist and I am super appreciative of the links.
I am under the impression that PARP correlates with PDL amplification which I don't have. It would be great to be wrong.
The Rosenberg trial has always been on my list, since it made headlines. I was under the impression I should get through the more traditional options first. Well, I have gotten through most of them at this point.
I have mostly switched methodologies at every hop. CDK4 to chemo to endocrine to chemo to endocrine. I was thinking to revert to CDK4, since it has been 4 years, if nothing else was promising.
Any info on people revisiting CDK4s?
0 -
Mikainsb,
No info about what you are seeking, but I'm sure you know that the Rosenberg trials (there are 2) are extremely difficult to get into. My oncologist says it's because they are looking for the perfect tumor so they can demonstrate results.
0 -
mikainsb,
I was on Ibrance for 20 months starting in 12/2016. Tried Verzenio last year and it worked for 6 months.
At this point, I'm happy to get 6 months.
Hugs, Susan
0 -
MIka, Susan is right about Verzenio, some people have gotten 16 months in late line, and apparently it works well on liver mets.
The MONARCH 2,3 trials had over half of the 132 patients having more than 3 sites of mets, and with a median of least 3 prior therapies for MBC. Overall anti-cancer responses were seen in nearly 20% of patients where the median duration of the response was nearly 9 months;whereas over 70% (of those patients who responded) got a median response of at least 6 months. So Susan fits right in there with those numbers!
You still would take that with endocrine therapy, here is one trial that has giredestrant with 1) Abemaciclib 2) Ribociclib 3) Ipatasertib 4) Inavolisib 5) Everolimus or 6) Samuraciclib (CDK7 inhibitor)
0 -
Just chiming in. I got 15 months out of Verzenio. Mind you, technically Ibrance did not fail earlier - I failed Ibrance with wonky blood.
0 -
Good afternoon. Can Ribociclib be used with Faslodex? Ribociclib - letrozole - increased breast tumor after 2 years.
0 -
Dear Savaloko: yes to R+F (https://www.nejm.org/doi/full/10.1056/NEJMoa191114...). But note that there's no comparison studies R+F vs R+L (https://www.nejm.org/doi/full/10.1056/NEJMoa211466...). Although from the first look it seems results from these two studies can be easily compared and R+L seems to be a superior combo, it might be wrong because of designs (randomization?) of Monaleesa-2 and 3. Please note that Monaleesa-2 has more mature results than Monaleesa-3 as it is an older study. Very important: we talk here about 1st line of therapy.
Saulius
0 -
thanks for the info
I don't even know what to do. In 2019, they said that the tumor in the mammary gland is inoperable due to its size. Was 8.3 by 4.2 centimeters.
After ribaciclib, it greatly decreased, but now it has slightly increased again.
Now it is in size: 31 - 14 - 35 mm and everyone writes for sure that it is inoperable Her2neo/c-erb-b2-1(+) - Estrogen - 100%0 -
Are letrozole and anastrozole the same thing?
0 -
Dear Savaloko, letrozole is same in class as anastrozole (aromatase inibitors - AI). They both interrupt the production of estrogen. I do not know the main difference between them (maybe someone knows?). Meanwhile fulvestrant is a SERD (selective estrogen receptor degrader - name speaks for itself), so a different class of drugs. I think maybe you could also search for other threads where people discuss AIs/SERDs? it is interesting that tumor that size is "inoperable", I wonder why, what is the reason?
Saulius
0 -
Dear Bsandra! Metastasis is small in the lungs and fluid. But the liquid is only 15 mm. But they say that even if there were no Mets, then it's still impossible to operate on the mammary gland
0 -
savaloko, I’m not sure how much help I can be but suspect the recommendation would be to move from ribo to a different CDK inhibitor with a change to Fulvestrant. It’s difficult to know if the AI failed, the ribociclib, or both. I anticipate the recommendation would be Verzenio as it acts differently than Ibrance/ribo which are quite similar. Like Saulius, I am not aware of the exact difference between Anastrozole and Femara - both are AIs - I believe Femara may be slightly stronger (I had trouble tolerating it in the adjuvant setting so was switched to Anastrozole (Arimidex). I had a couple of years on Faslodex alone and then layered on Verzenio (strategic decision based on timing and access to the drug here in Canada). This gave me another year plus.
I am wondering why you want to avoid chemotherapy. I understand to some extent but please understand that not all chemotherapeutic drugs are as difficult as you might imagine. The reason I ask is that my MO would want to go to a chemo next before going back to endocrine treatments. It’s his pattern to switch back and forth to try to avoid endocrine resistance as long as possible. With this in mind, you might want to consider Xeloda (Capecitabine). It’s an oral chemo which is very well tolerated. I’m currently back on it. It worked very well on my liver mets, although it does impact my bone marrow and I’m hoping to see good results again. Just a thought. There are ladies on here who have been on Xeloda for years.
0 -
Dear sadiesservant
About chemotherapy. My personal opinion is that chemotherapy is very hard on the body. Many people get much worse just because of chemotherapy and I believe that it should be done only in exceptional cases. I don't understand why, for example, a lung metastasis can't be removed surgically instead of chemotherapy. Indeed, in many cases, it works.0 -
Dear Savaloko, I second Sadies (her knowledge and experience is outstanding) - there are different modern chemotherapies that can beat back disease very quickly in certain cases. Lung surgeries are complex and taxing on the body - I believe you meant some type of targeted radiation surgery like SBRT? That can be done. The ESMO'21 guidelines (below) give several possibilities depending on what happens and what your preferences/gut feeling/oncologist tells.
Saulius
0 -
Thank you for your reply, Bsandra.
No. I meant physical intervention surgical. In some cases, this also works. Yes, they are complicated, but if it works, you can do without a huge amount of chemotherapy.0 -
There is still very little proof really that surgery helps metastatic breast cancer patients. It does seem to help colorectal cancer pts & some prostate pts & they have many of their mets surgically removed but in the metastatic breast cancer setting, there is no indication that surgeries are extending overall survival. The reasons for this are being investigated by various researchers who are also trying to come up with an actually effective therapy for MBC. What we know now is that breast cancer is much more likely to have constant tiny unmeasurable collections of cancer cells throughout the body which are in various phases of dormancy & without systemic treatment they wake up and grow and become finally eventually measurable on scans. Even with systemic therapy, eventually the therapy stops working & these cells come to life. I have heard of some people who pushed for both radiation & surgical interventions but ended up with massive cancer growths all over in just a few months later.
Also, just fyi, triple neg patients start chemo right away because that's the only treatment we have (even when we use immunotherapy, it's used with chemo). I've been on chemo for 26 months straight right now.
0 -
savaloko,
The way I see it, if you have just a few tumors or bunches of tumors close together, surgery can be a good choice. These kinds of tumors can also be treated with radiation which has almost no downtime. However, if your tumors are spread out over separate areas, you need to use systemic therapy. I agree with SadieServant that Xeloda is very tolerable and easy to take since it is in a pill form, not IV. Abraxane is another chemo that I found easy to tolerate and effective. There are certainly old-school chemos that are harsh. These are usually given to early-stage patients with aggressive cancers.
Hugs, Susan
0 -
Savaloko,
I agree with moth that removing tumors surgically or with radiation may not prolong survival. For example, my MO was against radiating my liver tumor because she said it might damage my liver and a new tumor would pop up anyway. I have seen that kind of result from others.
If the tumor is impinging on another area and causing pain or damage, removing it can make sense. For example, recently, I had a lung tumor that was eroding some of my lower ribs. I had radiation for that area.
After my initial Stage IV diagnosis, I had whole brain and eye radiation, radiation to a large mass in my lung, and a bit later, radiation to my femur bone where there was one small tumor. The brain, eye, and femur bone radiation were effective but my lung eventually progressed.
Like all of the other decisions we have to make, there is often no obvious path to take. I rely on the experience of my MO to guide me.
Hugs, Susan
0 -
A new paper published in Science reports that progression of HER2-positive MBC can involve over-expression of the AXL gene, sometimes as early as two weeks after starting treatment, and that this can be very effectively treated with an AXL kinase inhibitor (TP-0903), which then restores sensitivity of the cancer to anti-Her2 drugs. When expressed at high levels AXL can bind to HER2 and turn on the PI3K/MAPK pathway.
https://www.science.org/doi/10.1126/sciadv.abk2746
from the paper: ....all animals treated with this combination (anti-Her2 and TP-0903) remained tumor free for over 211 days after therapy discontinuation. This observation also suggests that the combination of HER2 and AXL inhibition might avoid treatment escape by tumor cells with acquired trastuzumab resistance, leading to a potential long-term benefit for HER2+ BC patients.
Although they did not examine Her2-low cancers, AXL expression has been seen with other drug-resistant cancers, including TNBC.
In addition to its over-expression in quite a few cancers, AXL also has a role suppressing the immune system's ability to fight cancer., and it may reduce the effectiveness of checkpoint inhibitors, like Keytruda
https://www.onclive.com/view/axl-kinase-becomes-a-...
Another AXL-directed drug is bemcentinib (BGB324). "Because AXL is upregulated in nonresponders to immunotherapy, there is a rationale that AXL inhibition could improve the efficacy achieved with checkpoint inhibitors. To this end, bemcentinib has been shown to increase efficacy of checkpoint blockade in preclinical models, and to reverse immunosuppression in both animal models and patient samples."
This has been an active area of research so complanies have also isolated monoclonal antibodies to AXL and companies are using these to develop ADC (antibody directed chemo) and CAR-T approaches. The AXL gene does not get amplified nor mutated in cancers, it is over-expressed, so staining for AXL protein would be the preferred way to detect it...
0 -
Wow, dear Cureious, thanks, AXL is an interesting target, and even more interesting because it could help reverse her2 drug resistance. I was always wondering why there are just a few scientists working on resistance problems. I have also been observing Alpha-TEA clinical trial (https://clinicaltrials.gov/ct2/show/NCT04120246), as it also showed in preclinical models that it could reverse her2 resistance - worked super in mice. Have seen no results from clinical trial so far.
Saulius
0 -
Whatever happened to the Big Bayer Hope of 2021? Its been about a year since that news came out they were acquiring something that seemed to cure some tumors in mice and, like most things, radio silence since then.
0 -
Dear Sondra, you mean ErSO? Buyer has disposed it after buying "for scientific reasons". For me such buys, when you buy and then drop, raise a lot of questions. The spin-off (don't remember the university) said that they will continue to develop the drug themselves but I did not hear about it since then:/ I think we discussed this drug and what happened here in autumn. Maybe in another thread, I don't remember...
Saulius
0 -
Not sure if there have been any new updates on ErSO but I found this from December: https://www.thedenverchannel.com/news/national/breakthrough-metastatic-breast-cancer-treatment-hits-snag?_amp=true
0 -
I liked at the Facebook group that is linked in the article I referenced in my last post and it appears that you can get a better idea about what the current status on ErSO is from there.
0
