A place for those managing the ups & downs of a Stage IV/metastatic breast cancer diagnosis. Please respect that this forum is for Stage IV members only. There is a separate forum For Family and Caregivers of People with a STAGE IV Diagnosis.
Posted on: Dec 10, 2019 06:30PM
The ELAINE study is evaluating an investigational oral drug, Lasofoxifene, in postmenopausal women diagnosed with locally advanced or metastatic estrogen-receptor-positive, HER2-negative breast cancer with an ESR1 mutation who have had the cancer grow while being treated with an aromatase inhibitor in combination with a CDK4/6 inhibitor.
People are eligible to participate in the ELAINE study if they:
are postmenopausal women
have been diagnosed with locally advanced or metastatic estrogen-receptor-positive, HER2-negative breast cancer with an ESR1 mutation
have had the cancer grow while being treated with an aromatase inhibitor in combination with a CDK4/6 inhibitor
The ELAINE trial is being conducted at multiple sites around the United States.
For more information, to find a trial site near you, or to enroll, visit the ELAINE Trial page on Breastcancer.org:https://www.breastcancer.org/treatment/clinical_trials/featured/elaine
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Mar 8, 2020 06:16PM - edited Mar 8, 2020 06:24PM by Cure-ious
I am bumping this thread to have more discussion of SERMs and SERDs, as they are supposedly moving along the pipeline toward FDA approval (although taking a very long time, and we need to examine why that is, because its literally been years and years)
Lasofoxifene is a tamoxifen-type drug that works well on both ESR1 mutant and non-ESR1 mutant MBC . The ESR1 mutation is not usually seen in primary breast tumors, but is commonly found in cancers that have become resistant to AIs or Faslodex. The phase 2 trial has been going since last September.
Lasofoxifene + palbociclib was more effective at inhibiting liver metastasis than either drug alone and was more effective than fulvestrant + palbociclib at reducing metastasis to the liver and lungs.
Mar 9, 2020 02:15PM pajim wrote:
You can take this with a several grain of salt. I discussed these drugs with a clinical trialist (not my MO). Most of them have severe diarrhea as a side-effect.
The Stage 4 ladies don't mind putting up with some of that, but the drug companies are looking to the big market. Early stage ladies. Substitute for tamoxifen. So they keep going back to the drawing board to re-formulate the compounds in hope that the SEs will go away. At least that was his take on the situation.
There was a discussion of Faslodex on these boards a couple of years ago. It was with a Ph.D. scientist who said that Faslodex was not really formulated to be used in humans. Who would formulate something that you have to inject castor oil in order to get it to work? It's a major-league imperfect drug. AZ brought it to market anyway.
Mar 11, 2020 09:12PM - edited Mar 11, 2020 09:15PM by Cure-ious
well, I was reading one discussion where they wanted to argue the SERDs were working "as well as Faslodex" whereas the whole point was they were supposed to work better (and in cultured cell lines in the lab they are stronger)- so now the question comes to how well do we understand the molecular details about exactly how Faslodex works, because maybe they need to know that and change their assay to develop something better, because the drugs they have been coming up with are not better in humans. So, if Faslodex was designed for something else, it seems we have lucked out getting it as an FDA-approved drug for as long as its been around, because they are having such trouble over a decade not coming up with anything better!
Mar 12, 2020 01:24AM ShetlandPony wrote:
I would be satisfied with a drug that only works as well as Faslodex if I could take it as pills or infusion instead of those horrid shots. Faslodex is inhumane. And isn’t castor oil poisonous?
Mar 12, 2020 03:09AM ShetlandPony wrote:
Horrid from the beginning. I want to get a long time on this trial but I can’t imagine taking these shots for a long time. Seems as if there won’t be any place left that isn’t scar tissue.
Mar 12, 2020 11:42AM pajim wrote:
I took it for four years and am back on it. Have 60+ holes in each buttcheek. And one permanent lump on the right side. Back in the day I weighed more so there was more butt to attack. Even now there's still some. I don't know how the really thin women do it.
This is the thread where the Ph.D. scientist discussed Faslodex as a drug.
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