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

Forum: Stage IV/Metastatic Breast Cancer ONLY — Please respect that this forum is for members with stage IV/metastatic breast cancer ONLY. There is a separate forum for caregivers and friends: Caring for Someone with Stage IV or Mets.

Posted on: Nov 29, 2018 07:40AM

Posted on: Nov 29, 2018 07:40AM

Kattysmith wrote:

I am about to start a clinical trial and am wondering about the experiences of others. I'm feeling a little rocky and at sea, because I've been in the care of a wonderful oncologist for the past three years, and I knew without a doubt that his prime objective was the same as mine - to keep me stable and maintain a good quality of life. It was all about me.

Now, I'm embarking on this trial on a different campus and with a different doctor. I really like the doctor who heads it (he is a close colleague of my oncologist and has conferred with him), but I not-so-secretly worry that the prime focus will not be on my well-being, that it will be secondary to the study objectives. My initial meeting with the CO pretty much dispelled my fear that I would be a lab rat, but the closer I get to starting, the more leery I get. I'm normally not anxious about treatments.

I haven't had any treatment at all for several weeks, because the last treatment was ineffective and my onc wanted to get me into a trial, so the waiting hasn't helped. I'm normally pretty chill about everything, including starting new treatments, but entering a clinical trial is a different kettle of fish.

What has been your experience? Have you felt cared for?

First diagnosed borderline Stage 2 IDC, left breast in 2003. No problems until a surprise (!) Stage IV recurrence in 2015! In addition to treatments listed below, I started monthly injections of Xgeva for bone support in July 2016. Dx 10/23/2015, Left, Stage IV, metastasized to other, Grade 3, 0/3 nodes, ER+, HER2- Chemotherapy 11/4/2015 AC Hormonal Therapy 2/5/2016 Femara (letrozole) Targeted Therapy 2/5/2016 Ibrance (palbociclib) Immunotherapy 12/23/2018 Hormonal Therapy Faslodex (fulvestrant)
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Jun 20, 2022 10:25PM newgardener wrote:

Hey folks,

Just a short update that my second set of CT scans were good enough to keep going on the enfortumab vedotin trial, although my oncologist will be reducing the dose for the second time. I'm still crazy fatigued and sporting the Pleurx catheter (fluid is down but persistent). I have to say this isn't my favourite treatment. But, hey, its keeping me going.

Key recap - enfortumab vedotin is an ADC (like Enhertu/Trodelvy) that is used in urothelial cancer and is now being tested in other cancers. I've now had 4 cycles (a cycle is 4 weeks).

GG27 - Great news that the tomivosertib is keeping you stable and gardening, but frustrating that it's now hard to get the drug. Hopefully we'll see the published results soon.

Sadiesservant - Hope the scan results from today are okay. FYI. My trial may be going on in B.C. https://clinicaltrials.gov/ct2/show/NCT04225117 Though I recognize I haven't given the drug a glowing review.

SusaninSF - I'm sorry that you have progression again and are back looking for your next treatment.

Rosie24 - good luck as you start your new trial

Everyone - thank you for your updates and sharing of information - I really appreciate it!



Dx 2004, Stage IIA, ER+/PR+, HER2- Surgery 11/23/2004 Mastectomy; Mastectomy (Right) Chemotherapy 12/27/2004 AC + T (Taxol) Hormonal Therapy 4/1/2005 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone) Dx 2010, IDC, Stage IV, ER+/PR+, HER2- Hormonal Therapy 2/1/2010 Femara (letrozole) Surgery 3/1/2010 Hormonal Therapy 4/1/2012 Faslodex (fulvestrant) Targeted Therapy 10/22/2013 Afinitor (everolimus) Hormonal Therapy 10/22/2013 Aromasin (exemestane) Chemotherapy 11/4/2014 Xeloda (capecitabine) Hormonal Therapy 7/19/2015 Targeted Therapy 7/19/2015 Targeted Therapy 7/27/2017 Targeted Therapy 1/23/2018 Hormonal Therapy 1/24/2018 Faslodex (fulvestrant) Targeted Therapy 10/8/2019 Chemotherapy 11/25/2019 Taxol (paclitaxel) Targeted Therapy 9/29/2020 Targeted Therapy 2/27/2022 Targeted Therapy Verzenio
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Jun 22, 2022 12:56PM gg27 wrote:

Day 15 of cycle 15, Abraxane cancelled due to severe neuropathy in my feet. Nothing seems to be helping at this point. I've tried ice socks at chemo, acupuncture, cool water baths with massage afterwards. Dr's recommend keeping my feet warm, well, my feet are burning hot, so that's not happening. We'll see what an extra 2 weeks off does for me. Staying on the trial drug.

Dx 10/2008, IDC, Both breasts, 3cm, Stage IIB, Grade 2, 3/9 nodes, mets, ER+/PR+, HER2- Surgery 1/8/2009 Lymph node removal; Mastectomy; Mastectomy (Left); Mastectomy (Right) Chemotherapy 2/1/2009 Other Radiation Therapy 7/5/2009 Whole breast: Breast, Lymph nodes Dx 5/14/2014, IDC, Both breasts, Stage IV, metastasized to bone/liver/other, 9/20 nodes, mets, ER+/PR+, HER2- Chemotherapy Abraxane (albumin-bound or nab-paclitaxel)
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Jun 22, 2022 05:25PM newgardener wrote:

GG27 that sounds horrible.

At one point can you just stop the Abraxane because of the side effects but stay on the study drug? Are they synergistic? Can they reduce your Abraxane dose?

I've been lucky with neuropathy - just pain and numbness but nothing like what you describe. And my feet are cold not hot. I had it during the 8 months I was on weekly paclitaxel, and it improved once I stopped but I do have it again on this trial.

Dx 2004, Stage IIA, ER+/PR+, HER2- Surgery 11/23/2004 Mastectomy; Mastectomy (Right) Chemotherapy 12/27/2004 AC + T (Taxol) Hormonal Therapy 4/1/2005 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone) Dx 2010, IDC, Stage IV, ER+/PR+, HER2- Hormonal Therapy 2/1/2010 Femara (letrozole) Surgery 3/1/2010 Hormonal Therapy 4/1/2012 Faslodex (fulvestrant) Targeted Therapy 10/22/2013 Afinitor (everolimus) Hormonal Therapy 10/22/2013 Aromasin (exemestane) Chemotherapy 11/4/2014 Xeloda (capecitabine) Hormonal Therapy 7/19/2015 Targeted Therapy 7/19/2015 Targeted Therapy 7/27/2017 Targeted Therapy 1/23/2018 Hormonal Therapy 1/24/2018 Faslodex (fulvestrant) Targeted Therapy 10/8/2019 Chemotherapy 11/25/2019 Taxol (paclitaxel) Targeted Therapy 9/29/2020 Targeted Therapy 2/27/2022 Targeted Therapy Verzenio
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Jun 22, 2022 08:05PM - edited Jun 22, 2022 08:09PM by cure-ious

Just today the first SERD was filed for FDA approval, Elascestrant- they request priority review, if accepted then the drug could be available in doctor offices in about eight months. In the trial, Elascestrant beat Fulvestrant on ESR1 mutant cancers, however, they never released the data for non-ESR1 cancers, which makes this kind of a mess and so will be interesting to see if the FDA considers this as a drug for all ER-positive MBC, or just ESR1 mutant cancers, or maybe make them go back and do another trial? (surely not)...

https://www.medscape.com/viewarticle/975720

https://www.onclive.com/view/dr-lin-on-the-advanta...


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Jun 22, 2022 08:43PM - edited Jun 22, 2022 08:50PM by cowgal

Cure-ious, forgive me for my ignorance but I thought this drug had failed or do I have it mixed up with another oral SERD?

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Jun 23, 2022 02:25AM gg27 wrote:

newgardener

I am already quite dose reduced on the Abraxane, down to 65% I think. The trial won't let me stay on it without either Abraxane or paclitaxol, I think I can take 28 days off, just shy of the 30 day cycle. I had anaphylaxis on paclitaxol 4 times, so not going back on that. I guess I'll see how this 2 weeks goes. Cold feet, OMG, I would kill for cold feet!!

Dx 10/2008, IDC, Both breasts, 3cm, Stage IIB, Grade 2, 3/9 nodes, mets, ER+/PR+, HER2- Surgery 1/8/2009 Lymph node removal; Mastectomy; Mastectomy (Left); Mastectomy (Right) Chemotherapy 2/1/2009 Other Radiation Therapy 7/5/2009 Whole breast: Breast, Lymph nodes Dx 5/14/2014, IDC, Both breasts, Stage IV, metastasized to bone/liver/other, 9/20 nodes, mets, ER+/PR+, HER2- Chemotherapy Abraxane (albumin-bound or nab-paclitaxel)
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Jun 23, 2022 11:51PM - edited Jun 23, 2022 11:52PM by cure-ious

Cowgal, Elascestrant was the first SERD to finish its trial, and it was a positive outcome, if only barely. It's hard for these trials to show benefit because the SERDs are being tested as monotherapy, in second or later lines for people who already took AI and/or Faslodex with CDK4,6i- and the SERDs are being tested against standard-of-care, which in most cases would have been an AI alone or fulvestrant alone, for which there is no reason to think those would even work in that situation. In those conditions, those taking elascestrant got an average 2.8 months PFS, compared to 1.9 months for standard-of-care endocrine therapy. What really saved this particular trial was they had a subgroup with ESR1 mutant cancers, which do not respond at all to AIs, and are only weakly inhibited by Faslodex (which varies, depending on the particular ESR1 mutation). When they pulled out the data for the ESR1 group only, the results were better, 3.8 months PFS vs 1.9 months with standard-of-care. Because these ESR1 mutant cancers were included in the data for the overall group, this means that those with cancers that did not have ESR1 mutations did worse than the 2.8 months PFS, but the company did not tell us what their numbers were, or if the benefit was statistical. Hence, the discussion of whether elascestrant would be approved for all ER-positive MBC or just for the ESR1 mutant MBCs.

After this trial, several other SERDs failed their phase 2 trials, and it was pointed out that these trials did not specifically recruit an ESR1 subgroup. Therefore, the results from these trials may have looked more like what happened with Elascestrant in non-ESR1 mutant cancers, and any benefits they showed over AI/Faslodex alone weren't big enough to be statistically meaningful. But these PFSs are low because they are being tested as monotherapy, and the benefit is of course in combination with CDK4.6i or other targeted drugs. So we wait and hope the numbers with SERDs are big enough to pass muster in combination trials.

https://www.onclive.com/view/fda-approval-sought-f...


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Jun 25, 2022 11:36AM cure-ious wrote:

A new study shows that in lobular cancers, a specific Her2 gene mutation (L755S) contributes to aggressiveness of lobular cancer cell growth. Interestingly, the same mutation did not have this effect in ductal tumors. They go on to show that this mutation is resistant to Neratinib but is very sensitive to the drug Poziotinib.

https://www.sciencedaily.com/releases/2022/06/2206...


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Jun 26, 2022 04:01PM nkb wrote:

Thanks Cure-ious! so glad they are finally looking at some drugs for metastatic ILC.

Dx 12/2011, ILC, Both breasts, 6cm+, Stage IIIC, Grade 2, 34/40 nodes, ER+/PR+, HER2- Surgery 2/4/2012 Lymph node removal; Lymph node removal (Left): Underarm/Axillary; Lymph node removal (Right): Underarm/Axillary; Mastectomy; Mastectomy (Left); Mastectomy (Right) Chemotherapy 2/28/2012 AC + T (Taxol) Radiation Therapy 9/11/2012 Hormonal Therapy 10/21/2012 Arimidex (anastrozole) Dx 5/2017, ILC, Stage IV, metastasized to bone, ER+/PR-, HER2- Hormonal Therapy 6/1/2017 Faslodex (fulvestrant) Targeted Therapy 6/1/2017 Ibrance (palbociclib) Targeted Therapy 3/13/2019 Afinitor (everolimus) Hormonal Therapy 3/13/2019 Aromasin (exemestane) Chemotherapy 3/10/2020 Xeloda (capecitabine)
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Jun 26, 2022 09:48PM - edited Jun 27, 2022 12:23AM by cure-ious

A recent Nature paper reports MBC mets are predominantly released and migrate into bloodstream during sleep (thanks to Luce for pointing out this paper!). Most circulating tumor cells (up to 80%) were present in nighttime blood collections, there was a large dropoff in CTCs collected during the day. Researchers are assessing whether this is true of all cancer, or is somehow specific to MBC.

"Our research shows that the escape of circulating cancer cells from the original tumor is controlled by hormones such as melatonin, which determine our rhythms of day and night (melatonin levels increase at nightfall and plays a role in turning on genes that are active at nightime)".. Levels of certain other hormones, like Insulin and glucocorticoids, are higher in the daytime than at night, and when the researchers introduced these hormones at night, they found a drop in the release of metastatic cancer cells. So its helpful to know that anti-cancer drugs are most effective during sleep.

The mechanism is not know, but one possibility is that it involves EGFR signaling, which is active at night and has been shown to stimulate metastasis. Studies are needed to look at the tumor microenvironment in day versus evening.

https://www.sciencealert.com/breast-cancer-spreads...

https://www.sciencedaily.com/releases/2022/06/2206...



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