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Topic: Could There Be Some Real Hope on the Horizon for ER/PR+?

Forum: Hormonal Therapy - Before, During, and After —

This is a safe place to share your experiences of others considering or on hormonal treatment.

Posted on: Jul 24, 2021 05:34PM

ThreeTree wrote:

I just came across this article and thought I'd share. Wasn't quite sure just where to post, but since hormone therapy is an ER/PR+ thing, I thought I would put it here. This new study looks amazing - maybe too good to be true? They've got some ways to go yet of course; as it hasn't even been tested yet in humans, but I did find this "inspirational" and hope inducing myself. Apparently this is a new drug that targets estrogen receptors, but not at all in the same way AI's do. At least in animals, it appears to have "no detectable" side effects either, but just seems to wipe out tumors large and small, real fast! Mets too! Let's all cross our fingers for this one!

https://www.sciencedaily.com/releases/2021/07/210722113058.htm


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Jul 24, 2021 06:14PM Beesie wrote:

There is a other thread on this:

Topic: New approach eradicates breast cancer in mice https://community.breastcancer.org/forum/73/topics...


Unfortunately, the chances that any mouse trial will turn into a treatment that works on humans is slim:

Lost in translation: animal models and clinical trials in cancer treatment https://www.ncbi.nlm.nih.gov/pmc/articles/PMC39022...


"Animal models have not been validated as a necessary step in biomedical research in the scientific literature. Instead, there is a growing awareness of the limitations of animal research and its inability to make reliable predictions for human clinical trials. Indeed, animal studies seem to overestimate by about 30% the likelihood that a treatment will be effective because negative results are often unpublished. Similarly, little more than a third of highly cited animal research is tested later in human trials. Of the one-third that enter into clinical trials, as little as 8% of drugs pass Phase I successfully."


After Phase I trials, there are Phase II and Phase III trials. Only 19% of drugs from Phase I trials end up being approved.


The Current Status of Drug Discovery and Development as Originated in United States Academia: The Influence of Industrial and Academic Collaboration on Drug Discovery and Development https://www.ncbi.nlm.nih.gov/pmc/articles/PMC62261...


Doing the rough math, it puts the likelihood of success at 1/2 a percent. And from what I read, the average timeline is 12 years.


That's not to be negative, but realistic. I've been hanging around 'breast cancer world' for a long time and I've seen many of these amazing mouse studies. So far, I've seen no drugs for patients that come anywhere close to the same success.

But, maybe one day!


Dx 9/15/2005 Right, 7cm+, DCIS-Mi, Stage IA, Gr 3, 0/3 nodes, ER+/PR- ** Dx 01/16/2019 Left, 8mm, IDC, Stage IA, Gr 2, 0/3 nodes, ER+/PR-, HER2- (FISH) ** Surgery 11/30/2005 MX Right, 03/06/2019 MX Left ** Hormonal Therapy 05/2019 Letrozole
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Jul 24, 2021 06:20PM LoverofJesus wrote:

I saw another article somewhere on this that said clinical trials will be starting soon. Like this year.

Maybe I’m wrong I’ll try to find it.

Dx 5/22/2021, ILC, Right, 6cm+, Stage IIIB, Grade 2, 0/3 nodes, ER+/PR+, HER2- (FISH) Chemotherapy 6/15/2021 AC + T (Taxol) Surgery 11/2/2021 Mastectomy: Left, Right; Prophylactic mastectomy: Right; Reconstruction (left): Tissue expander placement; Reconstruction (right): Tissue expander placement
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Jul 24, 2021 06:28PM ThreeTree wrote:

Beesie - Thanks, great info. Yes, I have a feeling it's all too good to be true. I remember reading once about how beta carotene worked wonders on mice with lung cancer, so after all the testing they started giving it to human smokers with lung cancer, and they all got worse. It was cited as the classic example of how unreliable these animal studies can be. I also have been amazed at how many things I read that sound promising, but then they never get tested any further. I think a good deal of it has to do with funding, "science/research politics", profitability, etc. I do like to hope, though.

LOJ - Yes, it looks like Bayer is going to pick this up. They did do more than mice also.

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Jul 24, 2021 06:32PM mommamonaster wrote:

A little investigating, and I found out Bayer bought the rights to the drug almost a year ago, and has been working on getting in to clinical trials ever since.

I am inclined the believe that they released the information about it now because they're close to starting. They sat on it since last September, so they have to have a reason for letting the info out.

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Jul 24, 2021 06:51PM mommamonaster wrote:

Also read that an early version of the drug had "undesirable side effects", so they revamped it. Now has no side effects well above treatment levels in mice, rats and dogs. So this has been in development for quite some time.

Bayer paid $25 million for the initial right, with the potential to pay $345 million if the company that developed it hits all their milestone on time.




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Jul 24, 2021 07:09PM Beesie wrote:

There have been bunch of articles about this within the past 3 days, so there must have been a press release from Bayer. Here is one article:

Bayer's drug that turns a cancer-protective pathway toxic eradicates breast tumors in mice https://www.fiercebiotech.com/research/bayer-s-bre...


"Bayer picked up global rights to ErSO in September for $25 million upfront, and Systems Oncology is eligible to receive milestone payments of up to $345 million.

While the current study found the drug was well tolerated in mice and dogs, further safety analyses are needed before it can be tested in humans, the UIUC team said. The researchers also plan to explore ErSO's use against other types of ER-positive cancers."


This suggests that the clinical trial might not be imminent, if within the past 3 days Bayer have issued a press release saying that safety has not yet been tested in humans. I was digging, but the submission to the FDA (Investigational New Drug Application) to get the human trial process started is not available to the public.



Dx 9/15/2005 Right, 7cm+, DCIS-Mi, Stage IA, Gr 3, 0/3 nodes, ER+/PR- ** Dx 01/16/2019 Left, 8mm, IDC, Stage IA, Gr 2, 0/3 nodes, ER+/PR-, HER2- (FISH) ** Surgery 11/30/2005 MX Right, 03/06/2019 MX Left ** Hormonal Therapy 05/2019 Letrozole
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Jul 25, 2021 04:12AM Jelson wrote:

call me cynical but Bayer missed the boat on Covid-19 vaccines and I think this flurry of news articles is a pr effort aimed at investors. https://www.fiercepharma.com/pharma/gsk-bayer-stand-by-curevac-for-now-following-disappointing-covid-19-vaccine-trial-flow

Dx 4/17/2009, DCIS, <1cm, Stage 0, Grade 3, 0/0 nodes, ER+/PR+
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Jul 25, 2021 07:38AM ThreeTree wrote:

I keep thinking of the old adage: "If it sounds too good to be true, it probably is!"

I do think that industry money and politics plays a huge role in all of this and we are at the mercy of those things more often than not.

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Jul 25, 2021 10:00AM exbrnxgrl wrote:

Given that mouse trials don’t often translate into successful human drugs, I will contain my happiness over this one. I am not poo pooing the drug but until we have evidence of efficacy on humans I will refrain from doing the happy dance. I can’t read Bayers corporate mind but I’m not sure that there is evidence to suggest human trials are imminent. Of course I hope it’s successful but I will remain a skeptic until I see the results of human trials.

Bilateral mx 9/7/11 with one step ns reconstruction. As of 11/21/11, 2cm met to upper left femur Dx 7/8/2011, IDC, Left, 4cm, Grade 1, 1/15 nodes, mets, ER+/PR+, HER2- Surgery 9/7/2011 Lymph node removal: Left; Mastectomy: Left, Right; Reconstruction (left); Reconstruction (right) Dx 11/2011, IDC, Left, 4cm, Stage IV, Grade 1, 1/15 nodes, mets, ER+/PR+, HER2- Hormonal Therapy 11/21/2011 Arimidex (anastrozole) Radiation Therapy 11/21/2011 Bone Hormonal Therapy 6/19/2014 Femara (letrozole) Hormonal Therapy Aromasin (exemestane)
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Aug 6, 2021 11:27AM KateHanni wrote:

I think this is fantastic. Given that no pharmas are trying to create an AI with less side effects; this could be the answer. I wish they could get FDA emergency status to get through the human clinical trials faster!

Dx 1/25/2021, IDC, Left, 1cm, Stage IA, Grade 3, 0/2 nodes, ER+/PR+, HER2- (DUAL) Radiation Therapy 4/18/2021 Radiation Therapy 4/18/2021 Multi-catheter: Breast Hormonal Therapy 5/30/2021 Arimidex (anastrozole), Aromasin (exemestane) Surgery
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Aug 6, 2021 11:48AM Olma61 wrote:

I hope it works in the human trials. I also hope it will be applicable to Triple Positive folks like me. Anything to get off the AIs would be great. Even if I had to continue on H&P...

I will set an alert for this one

10/30/2017 Xgeva for bone mets 5/31/2018 Taxol finished! "If one just keeps on walking, everything will be all right” - Kierkegaard Dx 8/3/2017, IDC, Right, 2cm, Stage IV, metastasized to bone, Grade 2, ER+/PR+, HER2+ (IHC) Targeted Therapy 10/28/2017 Perjeta (pertuzumab) Targeted Therapy 10/28/2017 Herceptin (trastuzumab) Chemotherapy 10/30/2017 Taxol (paclitaxel) Hormonal Therapy 5/14/2018 Arimidex (anastrozole) Radiation Therapy 5/30/2019 External: Bone
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Aug 6, 2021 12:39PM KateHanni wrote:

I work for a healthcare non profit and not announcing a discovery of a new, very effective in mice, molecule is typical. If they released ErSO too soon to the public, every pharma would be in the race to finalize human clinical trials. Also, and I know I'm cynical here, I would think if this works on humans and eradicates their HR+ cancer that there would be tremendous pushback from the AMA/Oncologists, the radiation specialists, the equipment manufacturers, the entire breast cancer industry from top to bottom would be turned on it's head. I get it sounds counterintuitive, but it's the facts we've seen over and over again as treatments come to market it's a race to the finish to be 1st, and to have the highest efficacy with the least side effects.

Given my cancer is HR+, I'm very excited about this new drug as a possibility!

Dx 1/25/2021, IDC, Left, 1cm, Stage IA, Grade 3, 0/2 nodes, ER+/PR+, HER2- (DUAL) Radiation Therapy 4/18/2021 Radiation Therapy 4/18/2021 Multi-catheter: Breast Hormonal Therapy 5/30/2021 Arimidex (anastrozole), Aromasin (exemestane) Surgery
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Aug 6, 2021 12:40PM KateHanni wrote:

Amen. I feel the same way!

Dx 1/25/2021, IDC, Left, 1cm, Stage IA, Grade 3, 0/2 nodes, ER+/PR+, HER2- (DUAL) Radiation Therapy 4/18/2021 Radiation Therapy 4/18/2021 Multi-catheter: Breast Hormonal Therapy 5/30/2021 Arimidex (anastrozole), Aromasin (exemestane) Surgery
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Aug 6, 2021 12:52PM KateHanni wrote:

The reason the FDA keeps certain clinical trial information confidential is to prevent the other pharmaceutical companies from stealing the exact molecule and re-creating it. Also, this would prevent the competing (and I know how cynical this sounds) entities i.e. oncologists, radiologists, BC surgeons (The AMA) from criticizing it prior to the trials being completed. Imagine if this does work on humans how many oncologists, medical equipment manufacturers, Pharmaceutical companies that manufacture the aromatase inhibitors, etc. will be put out of business and/or have their businesses severely financially impacted by a drug that eliminates 70% of breast cancers! Awful, but true.

Dx 1/25/2021, IDC, Left, 1cm, Stage IA, Grade 3, 0/2 nodes, ER+/PR+, HER2- (DUAL) Radiation Therapy 4/18/2021 Radiation Therapy 4/18/2021 Multi-catheter: Breast Hormonal Therapy 5/30/2021 Arimidex (anastrozole), Aromasin (exemestane) Surgery
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Aug 6, 2021 02:59PM ThreeTree wrote:

I've heard it said many places, that there is real incentive out there to not find a cure for cancer, but to keep coming up with these limited effectiveness things with bad side effects that can then all be added on to one another, because there is a whole industry out there dependent on not finding a cure. The feeling is that so many companies would go under and many people would no longer have jobs if they actually found a cure. I try not to be too cynical, but it is hard not to think that this is the case.

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Aug 6, 2021 03:42PM Beesie wrote:

KateHanni, yes, I am aware of why the FDA keeps this information confidential, but I still hoping to find some info on human trials. No luck on that though.

I don't buy that big pharma and the medical industry doesn't want to find a cure for cancer. 1 in every 2 men, and 1 in every 3 women will be diagnosed with cancer during their lifetime. This means that most of the people in big pharma and the medical industry have a loved one affected by cancer, if they have not been affected themselves. In a previous life I knew lots of people in the biotech and pharmaceutical industry, including medical directors and people working on drug development. Believe me, these people want to find a cure for cancer. Keep in mind too that a lot of the research takes place at universities and hospitals; it's not all done by pharmaceutical companies. I also knew someone who later became one of the top breast cancer researchers in the world. He turned his focus to breast cancer for a very personal reason - his wife died of breast cancer. Believe me, he wants to find a cure.

The reason we don't have a cure is because it's damned hard. It's because cancer is complicated; how many types of breast cancer are there, and how many subtypes within that? I was first diagnosed almost 16 years ago. I appreciate the progress I've seen. I wish it was more, but the future holds potential, with rMNA vaccines and the work being done with genes. Those are new areas where we may see huge breakthroughs, maybe not for my generation but hopefully for the next.

Dx 9/15/2005 Right, 7cm+, DCIS-Mi, Stage IA, Gr 3, 0/3 nodes, ER+/PR- ** Dx 01/16/2019 Left, 8mm, IDC, Stage IA, Gr 2, 0/3 nodes, ER+/PR-, HER2- (FISH) ** Surgery 11/30/2005 MX Right, 03/06/2019 MX Left ** Hormonal Therapy 05/2019 Letrozole
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Aug 6, 2021 03:57PM ThreeTree wrote:

I am aware that there are many who work in the industry because they really do want to find a cure, and I think they are truly admirable people. I've read articles that will feature a particular researcher and it is common to hear how their life's work to find a cure has been fueled by the experience of a loved one. While there are many individuals in the industry who are sincere about finding a cure and either a loved one or themselves have been affected, it seems that the industry as a whole can inadvertently work toward self preservation (most organizations do) and thwart some good efforts. I don't mean that individuals who work in the industry actually sit down together at a table and "plot" to keep a cure at bay, but I do think that the way large systems and organizations work and grow can can ultimately wind up discouraging and even thwarting positive developments.

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Aug 6, 2021 04:08PM Olma61 wrote:

In terms of industry not wanting to find cures - they will find them, but likely will make them expensive enough to compensate for lost revenue from lifelong treatments.

As an example -Zolgensma, a one shot gene therapy for spinal muscular atrophy in children:

https://www.npr.org/sections/health-shots/2019/05/24/725404168/at-2-125-million-new-gene-therapy-is-the-most-expensive-drug-ever


10/30/2017 Xgeva for bone mets 5/31/2018 Taxol finished! "If one just keeps on walking, everything will be all right” - Kierkegaard Dx 8/3/2017, IDC, Right, 2cm, Stage IV, metastasized to bone, Grade 2, ER+/PR+, HER2+ (IHC) Targeted Therapy 10/28/2017 Perjeta (pertuzumab) Targeted Therapy 10/28/2017 Herceptin (trastuzumab) Chemotherapy 10/30/2017 Taxol (paclitaxel) Hormonal Therapy 5/14/2018 Arimidex (anastrozole) Radiation Therapy 5/30/2019 External: Bone
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Oct 14, 2021 01:45AM Hamer1l wrote:

Hi everyone

I know there are mixed views on this potential drug but thought I would share a petition that has been started by a lady in Australia. Her daughter has been fighting MBC for 10 years.

I appreciate it is very early in development but new drugs have to start somewhere.

Please sign / share.

It gives me hope for the future.

X

https://chng.it/SJ9VJ4KYTk



Dx 3/5/2021, Left, Stage IV, metastasized to bone/liver/lungs, ER+/PR- Targeted Therapy 3/26/2021 Kisqali Hormonal Therapy 4/2/2021 Femara (letrozole), Zoladex (goserelin)
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Oct 14, 2021 02:48AM sunnidays wrote:

The cost is a really interesting question CAR-T cell therapy and treatment costs nearly five hundred thousand dollars, and there are is s stem cell treatment for childhood cancer that costs over a million dollars.

If a pharmacy company finds an effective treatment for certain cancer they make billions from it, cancer researchers who set up companies after they have developed a drug have become millionaires or even billionaires from the drugs they developed.


Dx 2/2021, ILC, Left, Stage IV, metastasized to bone, ER+/PR+, HER2-
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Oct 14, 2021 08:19AM PamEP wrote:

Thank you for sharing the link to the petition. I for one think that BC treatment needs to step it up, and I am sure I am not alone.

POSSIBLE BREAST CANCER CURE DRUG Petition

Dx 7/26/2021, DCIS/IDC, Right, 1cm, Stage IA, Grade 1, 0/4 nodes, ER+/PR+, HER2- (IHC) Surgery 8/6/2021 Lumpectomy: Right; Lymph node removal: Sentinel Hormonal Therapy 10/15/2021 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone) Radiation Therapy 10/27/2021 Whole-breast: Breast

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