Are you currently (or have you been) in a Clinical Trial?
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Hi Phet,
A couple of weeks ago you asked about the Tapestry basket trial.
I don't have an opinion about choosing atezo for TMB or inavolisib for pik3ca, but I thought I'd a least offer that I was on inavolisib for 18 months as my 7th or so line of treatment (with fulvestrant, inavolisib was still called GDC-0077). I found it quite tolerable - I seemed to do better than people with Piqray although I did develop hyperglycemia. I hope your friend can find a good option.
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Hello everyone. I had hoped when I started my clinical trial (Copanlisib/Verzenio/Faslodex) that I would be a regular correspondent, with good news. Sadly neither was the case. Almost immediately I was hyperglycemic, and developed an allergic reaction to Copan/Verzenio. I developed interstitial pneumonitis, was hospitalized and for a few weeks it was a near run thing on survival. I ended up on gargantuan doses of prednisone for 3 months, finally tapering during month 4, although that was complicated by restarting Verzenio and discovering that allergy. All ciclibs are now off the table. I held steady into May, but the length of the taper (only on Faslodex) allowed the cancer to explode. Multiple new bone mets, an adrenal gland, and the original mediastinal lymph nodes are now crushing my airways. I start Abraxane 13 September and am being fitted for a cold cap 30 August. Sorry for the bad news.
Movingsoccermom
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MovingMom, I'm so sorry that was your experience, but very grateful that you shared it here. Hopefully Abraxane will beat everything back in shape quickly!
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Pfizer just spent 2.3 billion to buy Trillium, a Canadian company developing a new immunotherapy (anti-CD47) that is very popular target in all cancers, and their drug is thought to be possibly best-in-class among those targeting CD47.
CD47 is especially high in aggressive triple-negative cancers, and it is a major mechanism cancer cells use to shield themselves from the immune system. This drug has relatively few side effects (its a monoclonal antibody) but it has been moving so slowly from one phase one trial to another, doing great in each trial, but the company either lacked the expertise or the cash (or both) to move it to the next step - with Pfizer guiding it, that should be changing now...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC66764...
In addition, a recent Nature Comm paper shows that HER2-expressing MBC turns on CD47, and blocking CD47 at the same time as HER2 gets rid of the therapy-resistant cells (so people can stay on the HER2-directed drugs for longer if they can also block CD47)
https://www.nature.com/articles/s41467-020-18245-7
https://www.pnas.org/content/118/29/e2026849118
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Alabama – thank you for the Q's to ask. It does sound like phase 2 is a better choice if an option. Another one for me is can it be locally administered. Could be a 5-8 hour drive to the 2 clinics I've been referred to for initial consultation, just to find out if there is a trial for me. Just don't think current treatments are working.
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Movingsoccermom, Wow! You went through so much. Glad you shared your path and hoping for a better response from Abraxane. Stupid cancer!
BGRS- I will add distance to trial center to the list! I know some people travel 6 hours at my clinic. Remember some great trials are labeled phase 1/2. Hope you find something that works
https://www.nashvillemedicalnews.com/erika-hamilton-md-cms-4900_
This article is about my trial doctor. I like what she said. "I often tell my patients a clinical trial is a way to access the drugs we may be using five or 10 years from now."
Dee
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Alabama - thank you for the link about Erika Hamilton. Helps to have a more optimistic attitude and not think about being a lab rat but trying something that might be in common use 10 years from now. Reminds me of my DIY cold capping. One clinic refused to let me try, and because I was not happy with the oncologist anyways, I switched clinics. The other clinic allowed it, and the MO and surgeon were very interested in the results because I was their first patient to try it. The MO even let my brother come into her office when it was time for me to change caps. The MO was impressed enough that she tried to get the clinic to provide DIGNICAP or other FDA approved.
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Hi all - I am so sorry to have posted a query then just disappeared! I've been struggling with treatment side effects these last weeks, after we combined chemo with a blast of radiation to my chest.
Cure-ious, Lili75 and New Gardener - thank you so much for your responses. I've told my friend about your good response to Inavolisib, New Gardener, and I really hope she's able to access it on this Tapistry trial. Her own team are very slow and seem to know nothing about trials but I've given her the details of the team overseeing the site in London so hopefully she can get on to them and get more info. It's frustrating at the moment in the UK as I feel like Covid has slowed down the opening of trials a lot and there's much less around and opening up than there should be.
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Posting an important point from a tweet by: Dr. Laura Esserman@DrLauraEsserman
"In light of the Texas law that prohibits abortion past 6 weeks of pregnancy AND promotes vigilantism, directly harming women and their caregivers, the 2021 SABCS breast cancer meeting should be moved out of texas to a place that supports Women's rights and public health"
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A new clinical trial is starting that combines Ibrance and Faslodex with Capivasertib, an AKT inhibitor (AKT is a kinase that promotes metastasis). Although it is well established how much of each drug can be used on its own, there is a phase one part that assesses how much can be used when all 3 are combined. It then moves to phase 3, enrolling 700 patients in US and internationally. Prior data indicated capivasertib doubled the response to I-F. Not more than one prior chemo in metastatic setting is allowed. Other trials are testing Capivasertib for mTNBC and Her2-positive MBCs. AKT is a great target so its good to see inhibitors move forward.
https://www.icr.ac.uk/news-archive/breast-cancer-d...
https://clinicaltrials.gov/ct2/show/NCT04862663#co...
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Cure-ious - I hope the effort to boycott works. If there is economic/political/social fallout, they might reconsider
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Dear all, it is so cool Covid-19 helped to advance mRNA technology that is coming into cancer world. What a great idea to make your body produce leukocytes with vaccine-induced cancer antigens. I think it will become another great tool in combination with existing drugs: https://www.fiercebiotech.com/research/biontech-re.... There's also a recruiting clinical trial there for solid tumors. In my list! Hooray!
Saulius
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Saulius - thanks for sharing. This concept sounds promising!
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Hi- I've been accepted into a FES PET trial this week but have questions about Medicare covering the soc (standard of care), a CT and possible biopsy. I have Kaiser coverage and have been talking to membership.
I'm told-Only the FES PET is covered by the clinical trial. All other procedures would be considered Standard of Care. SOC would include the CT and Biopsy (if needed).Kaiser says- if your trial says a CT and biopsy are needed, it will be covered by Medicare, the whole thing. They are the ones to bill and agree to pay the whole thing.
The clinical trials insurance team has said: Patient has a Kaiser Medicare Advantage plan. For Medicare eligible members original Medicare will cover soc (standard of care) services related to an approved clinical trial at 80%. Kaiser will then pay their cost share portion and bill the patient for any portion that is their responsibility. No Authorizations are needed for pt enrollment into trial or for any study related soc services.
soc is short for standard of care, meaning not covered by the trial. This would include the CT and biopsy if needed.i'm finding this medicare thing and trials a bit confusing. I'm will be communicating again tomorrow with the clinical trial people to further clarify and will pay out of pocket for the CT if is not approved (I already had PET last week but want a CT since nothing was found on the PET so technically the CT is not necessary since the PET is there for a comparison).
Thanks for helping me articulate the problem. NINA
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Abstracts were posted today for the ESMO 2021 conference, which will begin on Thursday- the link below has those that are pertinent to breast cancer:
https://oncologypro.esmo.org/meeting-resources/esm...
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Thanks, Cure-ious. Filtered on metastatic and not much came up. Anything that looks particularly exciting to you for ER+/HER2- MBC?
Hope says there aren't any trials for me right now because I have been on so many treatments. So hard to hear that since I have done so well on trials in the past. I don't understand why they don't develop more trials for the heavily pretreated. We're the ones who need it the most.
Hugs, Susan
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Hi Susan, I will look- one thing to ask Hope about is taking a PARP inhibitor- as I understand it, more people respond to that than just those with BRCA1 or other DNA repair gene defects, and its seems she ought to be able to prescribe that outside of a trial? Have you had immunotherapy? Sometimes PARPi is given with checkpoint inhibitors, or with chemo...
"In 2018, the FDA approved talazoparib for the treatment of deleterious germline BRCA-mutated HER2 negative metastatic breast cancer. Talazoparib is 100 times more potent than olaparib due to the mechanism of action of PARP trapping, which interferes with a cell's ability to replicate."
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ESMO will also have early results for a trial of CDK7inhibitor (Samuraciclib) with fulvestrant for endocrine-resistant MBC, which got the FDA fastrack designation last month
https://www.biospace.com/article/releases/carrick-...
and just announced a new trial with a SERD
https://www.globenewswire.com/news-release/2021/08...
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Guys, please check ESMO abstract 279p - TDXd has more mature data now from DESTINY-Breast-01 - the mOS increased to 28.4 months in comparison to last data which was 24.6 months. Great. They will also present ORR, mPFS, and mDOR during the conference.
Saulius
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I just wanted to share with you my tempus came back...nothing really stood out...except this:
I DO NOT HAVE: ESR1, PIK3CA, ERBB2
I do have 1 mutation called CHEK2 which MAY make me sensitive to a PARP inhibitor. USUALLY people that have this are BRCA positive I am not....There is a trial that my MO already found that she thinks I wold be a good fit for (for this).... called
Talazoparib
The trial number is https://clinicaltrials.gov/ct2/show/NCT02034916
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Hey Nicole, I also have CHEK2 mutation- which one do you have? There is a truncation that is most defective.
PARP inhibitors are very powerful drugs and have effects on more pathways than just DNA repair, so they are working hard to identify the many patients beyond those with a BRCA defect who might benefit. Studies with Eribulin (Halaven) show that those who benefit the most have DNA repair problems, so since you did well with Halaven you might also respond to PARPi.
But also, PARPinhibitors turn on the STING pathway and can make cancers become sensitive to immunotherapy, here from a recent review:
In advanced TNBC the combination of niraparib (PARP inhibitor) and pembrolizumab (Immunotherapy) demonstrated clinical benefit in 20 out of 46 patients, notably including 4 patients with no identified HR DNA repair defect or detectable PD-L1 expression
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Nicole- 2 things--- 1. The trial you posted says "Recruitment--- Terminated". 2. Why not ask about the PARP's that are out there now. I am on Lynparza. See if your MO would try it with your situation of no BRCA mutation but you have the CHEK2. Wouldn't hurt to ask or try a PARP (if insurance would agree).
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Kathy.... it says CHEK2 p.C420Y. Splice region variant - LOF 89%
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ESMO 2021: Early results for Samuraciclib (CDK7 inhibitor) in combination with fulvestrant for patients who progressed on AI+CDK4,6 inhibitor came out, PFS 33 weeks for those without TP53 mutations. Trial will continue and they will add more bone-only mets because that group did not reach PFS as yet. Side effects low grade GI problems, no neutropenia...Results for the Syros CDK7 inhibitor will be announced on Monday. The drug was fast-tracked last month, so they are pushing now and we may see updates in San Antonio.
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Cure-ious- this sounds exciting!
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Nkb, It's still just few people and somewhat modest results, but things do sound hopeful cuz they fast-tracked presumably based on some data, plus Syros also has a CDK7 inhibitor, and while their abstract indicates no responses the analysis I read suggested that was just a placeholder(?) and pointed out that they are giving an oral presentation Monday, which why would you stand up to speak if it were just to say "we got no responses"?, that makes no sense. For sure the lack of bad side effects is a big hurdle passed, and the pre-clinical work looks good, so we shall see Monday, if its good we will keep hearing about it. Pre-clinical said this is what to take for endocrine resistance.
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Cute-ious- doesn’t the FDA need some really hopeful results to fast track a drug?
Having few side effects seems like a big positiv
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Hi,
Does anyone know anything about the following trial:
Randomized Phase II Study of Sacituzumab Govitecan with or without Pembrolizumab in Hormone Receptor-positive (HR+) / HER2- metastatic Breast Cancer
I have reviewed all of the info on clinicaltrials.gov, but I am looking for more background information supporting the effectiveness of either of these drugs for HR+/HER2- MBC. As I understand it, both of these drugs are approved for triple-negative MBC. I am certain that there must be evidence supporting effectiveness of these drugs in HR+/HER2-, or else the trial would not have been IRB-approved. But I am having trouble locating any additional information.
Thanks!
TwinkleCat
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Exciting data out for secondline treatment of HER2-positive MBC from ESMO 2021:
Enhertu slashed the risk of disease progression by a massive 71.6% over Kadcyla in second-line HER2-positive metastatic breast cancer, reported at the European Society for Medical Oncology 2021 meeting.The showing is so impressive that the study authors concluded that the study, dubbed Destiny-Breast03, will lead to a paradigm shift in the treatment of HER2-positive breast cancer. The median time to disease progression or death was not reached for Enhertu, compared to 6.8 months for Kadcyla. By investigator's analysis, the median time to progression was 25.1 months for Enhertu versus 7.2 months for Kadcyla. In Destiny-Breast03, Enhertu also more than doubled the number of patients who responded to treatment, and shrunk tumors in about 8 of 10 its patients, while the rate for Kadcyla was just a little over one third.
"The investigators that we talked to start talking about maybe we're opening up the possibility for some women that a cure could be possible in advance disease".
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Anyone familiar with clinical trial, Dose Escalation AZD9833 (oral Fulvestrant) alone or with palbociclib/everolimus/abemaciclib) parts Gand H D8530C0001, AstraZeneca ? I might be eligible after an initial visit and review of health history. Logistics are a problem since it is a 6 hr drive one-way and fr the first 4-5 weeks require weekly visits.
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