Are you currently (or have you been) in a Clinical Trial?

[Deleted User]

GG27/Dee

So sorry you are experiencing difficulties. My trial nurse is the one who has to clear everything, to get rx approvals, etc . The doctor always refers to him about those things.

Hope you slept better.

AlabamDee

[Deleted User]

HER2CLIMB-04 (NCT04539938)

A new trial for Her2+ is a combo of approved drugs without xeloda! FYI-This is my trial MO, Dr Hamilton.

https://www.medpagetoday.com/meetingcoverage/ascov...

Both tucatinib (Tukysa) and trastuzumab deruxtecan (Enhertu) have been shown to be highly efficacious in the pivotal HER2CLIMB and DESTINY-Breast01 trials, respectively. A new study presented at the recent American Society of Clinical Oncology (ASCO) virtual annual meetingaims to assess if the combination of of the agents in patients with HER2-positive locally advanced/metastatic breast cancer can further improve the efficacy seen with either agent alone.

Dee

cure-ious

A new paper in Cancer Cell provides updated results from I-SPY2 showing that a subset of patients in each breast cancer subtype is able to respond to immunotherapy, when it is combined with a PARP inhibitor. This trial was looking at early stage cancers, but remarkable that almost a third of ER-positive patients were responders...

The findings showed patients receiving durvalumab plus olaparib improved estimated pathological complete response rates (over control) from 20% to 37% in HER2-negative cancers, from 14% to 28% in HR-positive/HER2-negative cancers, and from 27% to 47% in Triple Negative Breast Cancer (TNBC).

https://medicine.yale.edu/news-article/yale-cancer...

cure-ious

As I mentioned earlier, Foundation One showed that my cancer has a mutation in the SF3B1 gene, and new reports suggest that this can lead to increased neoantigen production in the tumor that predict that the cancer may respond to immunotherapy, despite having a low tumor mutation burden.

An exciting new paper in CELL now reports that certain drugs can mimic the effects of this mutation in cancer cells that do not have SF3B1 mutations, providing a new way to turn cold tumors hot. The two experimental compounds, one known as indisulam and the other called MS023, have never been approved by the Food and Drug Administration as cancer drugs, but belong to drug classes that do not appear to be toxic in early trials. PRMT1 inhibitors are also promising.

https://www.fredhutch.org/en/news/center-news/2021...

https://www.cell.com/cell/fulltext/S0092-8674(21)00690-5

illimae

Alabamadee, thank you for that, I’ll be following this closely. I’m currently on the H/X/T combo with minimal SE’s but I would love to drop the Xeloda (cape) as the joint/knee issues are slowing me down.

susaninsf

GG27,

What trial are you on? Your MO thinks you had an anaphylaxis reaction to the premeds? I was on nab-paclitaxol because I developed restless leg syndrome from one of the Taxol premeds. If your reaction was from the taxol and not the premeds, nab-paclitaxol won't be any better. You and your MO probably already know this. It is just taxol coated in Albumin to eliminate the need for premeds.

Hugs, Susan

GG27

hi Susan,

I'm on tomivosertib & paclitaxol, not sure what the trial name/number is. It's not the premeds that's the problem it's the taxol. Maybe that's why I still haven't heard whether I'm still on the trial or not, they are trying to figure out what to do about me? She did say that they had way fewer reactions to the nab-paclitaxol than taxol. So I was just doing some reading & saw this

"Abraxane (nab-paclitaxel), an albumin-bound form of paclitaxel, has a different toxicity profile from solvent-based paclitaxel and a lower rate of HSRs (hypersensivity reactions). Interestingly, several authors have recently reported cases of patients who developed HSRs to taxanes, principally paclitaxel, and were then safety treated with Abraxane, suggesting the absence of cross-reactivity between these drugs"

MO also indicated to me that B.C. Cancer had changed the way they gave paclitaxol & they were seeing way more serious reactions than previously, but I was too stressed to ask for further details (I was trying to breathe etc...

I'm happy to see you & have your opinion. We were on the alpelisib trial at the same time, what a nightmare that was for me. I'll post where I go from here.

cheers, dee

illimae

GG27, I had severe reactions to taxotere and taxol, both were stopped immediately and taxol landed me in the ER. I requested we give abraxane a try because of what I read on BCO of others experiences and I had had no reaction issues at all. I was on premeds though, even when not required for abraxane, just as an extra precaution. Good luck!

GG27

thanks for your experience illimae. Do you remember the premeds you had/took? I had a phone call today that I will be getting chemo on Tuesday, but the RN had no idea what as it's on a trial & the trial doesn't play well with others, like sharing any information. cheers, dee

ShetlandPony

WTF Dee. It's terrible that you were subjected to FOUR episodes of anaphylactic shock. It's ludicrous that you can't even know what they are planning to put in your body next week. What happened to informed consent? I would raise hell. (Can you tell that ShetlandPony is angry on your behalf? She doesn’t often swear.) Your hospital must have a safety officer for trials and/or a patient advocate you can contact.

sandibeach57

Yes, what Shetland Pony said. Something not right. Are you getting ANY treatment inbetween reactions?

GG27

thanks both of you for your outrage on my behalf.

I have emailed my trial RN to find out what is going on. I thought if I was to get nab-paclitaxol that they would start it on day 1 of cycle 3, but Tuesday is day 15 of cycle 2, so who knows. If they don't have a good plan, I will have them get my MO up to the chemo room immediately to talk to me & I will not allow them to give me paclitaxol again. Not to worry, I am a very good advocate for my treatment. The only reason I put up with 4 treatments/ 4 reactions was because we kept trying different pre-meds to mitigate & I really, really want to stay on this trial. I am running out of options.... quickly.

I am on the trial drug tomivosertib daily at 50% because of a bad rash SE, so I am still getting treatment & they were able to give me the full dose of paclitaxol for the first 3 cycles after getting the anaphylaxis under control. My TM's dropped by 250pts last labs so that's encouraging. TM's are very accurate for me.

My MO is very good, but unfortunately she is not the lead investigator for the trial so she is relying on a colleague & the trial RN to keep her in the loop as to options that the trial will allow. I have been on several trials & it seems like they are all like this, keeping options close to the vest, as if they don't want anyone to know what they will allow, or maybe they don't even know??

i will post what happens on Tuesday. it should be an interesting day. cheers, dee

illimae

GG, I think it was just IV Benadryl and a steroid. I also had my abraxane weekly at smaller doses, I think the combo was easier and worked really well.

ShetlandPony

GG27, here is the thing -- the investigators need patients, so they don't hold all the power. I was worried about adjusting my dose and what would be allowed, and my onc gave me to understated that the main thing for the trail sponsor is to show efficacy, and that rules can be bent. I did find out that my onc fought to keep me on the trial when I had such a rough start, telling them the trial drugs were the right ones for me and no way were they taking me off. I am very glad to hear that you will advocate for yourself, and that you will refuse a fifth try of taxol. Something you said earlier made me think some of the nurses were following protocols with no nuances and that your onc was not consulted enough.

susaninsf

GG27,

So happy for you that the trial drug is working! I looked it up and it's a very small trial of 45 people. Canada-only sites. https://clinicaltrials.gov/ct2/show/NCT04261218

Hope we can get access to it in the U.S.

Hugs, Susan

cure-ious

The drug Dee is taking, Tomivosertib, is a potent and highly selective oral inhibitor of the MNK1/2 kinases, which act to promote tumor growth and also boost expression of proteins that help tumors hide from the immune system.The main targets are cancers with KRAS mutations, amplifications or fusions in HER2, ERBB3, and FGFR1 or FGFR2 receptor tyrosine kinases. Currently in phase 2 trials with immunotherapy in lung cancers that have high levels of PDL1

susaninsf

I think it's unfortunate that most of the Phase II or III trials seem to be in combination with Taxol or Ibrance. I and many others have already been on both.

cure-ious

From the "inclusions" section of the tomivosertib trial: Patient is a candidate for weekly paclitaxel as palliative treatment for the locally recurrent and/or metastatic disease in the opinion of the treating physician, or is currently receiving paclitaxel (achieving disease control or not). Note: any number of prior lines of standard-of-care or experimental therapies are allowed.

Meaning, they do not exclude those who previously were on paclitaxel, altho they do exclude anyone who tried some other MNK1,2 inhibitor- indicating there must be some evidence that tomivosertib can restore sensitivity to chemo-resistant cells.

But whether the patient is willing to go back to take paclitaxel again is a separate issue, of course

susaninsf

Interesting that you can stay on paclitaxel whether or not it is controlling disease. It's not an easy treatment so who would want to stay on it if it's not working? Happy to see that any number of prior therapies are allowed. This is usually what excludes me from trials.

Thanks for sharing, Cure-ious!

cure-ious

I think they mean that you could enter the trial even if currently on paclitaxel and its not even working or did not work previously (as monotherapy)- clearly, they think that the MNK1,2 drug can restore the cancer's sensitivity to paclitaxel.

GG27

It s my understanding of Tomivosertib that it opens up the cancer cells so that paclitaxol can do it's job better (laymans very simplified language) or at least that was kind of how it was explained to me. So Curious is right it restores the cancers sensitivity to chemo.

Susan, I too hope that it is available to you soon. cheers, dee

[Deleted User]

Dee

Hoping you can get abraxane instead. You have been through so much on your trial. Sounds like your MO could be an advocate. Fingers crossed.

AlabamaDee

susaninsf

Cure-ious,

Thanks for the clarification!

Hugs, Susan

bsandra

Dear all, this is so exciting: https://clinicaltrials.gov/ct2/show/NCT04539938?te...

Saulius

GG27

hi all!

Exhausting day today, CT @ 8am, only to be delayed by an hour, gawd that extra hour of sleep would have been great. Labs @ 9:30 & chemo @ 10:35. So the chemo wasn't ready because the labs weren't processed yet, well no kidding.... the left hand not only doesn't know what the right is doing sometimes, I believe they are attached to different people.

But I did get Abraxane & did NOT have any kind of reaction! Yippee!

It seems that it took a long time to get approval from the sponsor & then the changes had to go to the board of ethics.

Then the long trek home, the ferries are so busy it took almost 7 hours but I am home. I am on the off week now til the 26th. I hope I don't have to wait til then for the CT results. I will call her office on Thursday to see if they are in yet.

thanks everyone! cheers, dee

illimae

GG, great news on the abraxane, happy for you!

cure-ious

Enhertu is in more trials for HER2-low cancers. They are moving FAST on this drug!!

DESTINY-06 trial, phase 3, for HER2-low MBC.

https://clinicaltrials.gov/ct2/show/NCT04494425

Here they are testing Enhertu following progression on endocrine therapy, and comparing efficacy to standard chemo: Xeloda, Paclitaxel, or Abraxane. Exclusions: Progression on at least two lines of endocrine therapy, but no prior chemo in metastatic setting.

DESTINY-08 trial.

https://clinicaltrials.gov/ct2/show/NCT04556773

Enhertu combinations for TNBC or MBC. Two parts, Part 1 is dose-finding, they accept second or later lines, but then part 2 allows for only one prior line of endocrine therapy and no prior chemo.

1) Enhertu and Xeloda; 2) Enhertu and Paclitaxel and Immunotherapy (TNBC only); 3) Enhertu and Capivasertib (AKT inhibitor) (TNBC only); 4) Enhertu and Anastrazole (AI); 5) Enhertu and Faslodex

nkb

Cure-ious- do you need measurable disease or is bone only eligible. At UCSF they told me bone only was fine, but, that you needed two biopsies and she wasn't sure that a bone biopsy would count- so that is a little unhelpful for bone only. But, yeah- all new treatments that show promise are welcome- it could be the winner for some folks!

cure-ious

Nkb- That's a good point, they only say they need enough tumor sample for for biomarker determination, but its hard to biopsy bone mets- and this will be an issue with all these trials that may come for second or thirdline treatments, if they want to exclude people who have not yet had chemo, you would think they want to include bone-only, but can only do that if they can work with blood biopsies or have developed other easy assays...

ShetlandPony

GG27, yay, I'm so glad you got abraxane and it did not cause a reaction. What a strange life we live when scoring a chemo drug is cause for general celebration.