New Interesting Clinical Trials

[Bestbird]

There are some interesting drugs and clinical trials described below for MBC patients with HER2 positive or "HER2 low" disease (meaning that the patient is officially HER2 negative but has a HER2 IHC score of +1 or +2). This and other cutting edge research (as well as approved therapies in the US, Canada, Europe and Australia) can be found in my book, "The Insider's Guide to Metastatic Breast Cancer," which is also available in a complimentary .pdf. For more information, please visit: insidersguidembc.com/about

1) Trastuzumab Deruxtecan(DS-8201) Trastuzumab deruxtecan is a novel drug consisting of a HER2 antibody attached to a “topoisomerase I inhibitor” (a new class of anticancer agents that interrupt DNA replication in cancer cells). It has received an FDA “Breakthrough Therapy” Designation for the treatment of patients with HER2-positive, locally advanced, or metastatic breast cancer who have been treated with trastuzumab (Herceptin) and Pertuzumab (Perjeta) and have disease progression after ado-trastuzumab emtansine (T-DM1; Kadcyla).

The recent Phase 2 DESTINY BreastO1 clinical trial studied trastuzumab deruxtecan in 115 patients with unresectable and/or metastatic cancer who had previously received a median 7 lines of therapy including Herceptin and Kadcyla (as well as Perjeta in most cases). The patients in the study had either: HER2-positive breast cancer, HER2–low expressing breast cancer (considered HER2 negative), HER2-positive gastric cancer, or various other HER2-expressing solid tumors. Data revealed that the overall response rate with trastuzumab deruxtecan was 59.5% and the disease control rate was an impressive 93.7%. The median duration of response was 20.7 months, the median progression-free survival was 22.1 months, and the median overall survival has not yet been reached. From: targetedonc.com/news/fam-tr... (Note: As of July 2019 there are 3 recruiting clinical trials of trastuzumab deruxtecan for MBC patients: NCT03529110, NCT03523585, and NCT03734029).

2) Trastuzumab Duocarmazine (SYD985) The FDA has conferred Fast Track designation to trastuzumab duocarmazine for the treatment of patients diagnosed with HER2-positive MBC who have progressed during or after at least two different HER2-targeting treatment regimens for MBC, or who have progressed during or after treatment with Kadcyla. “Duocarmazine” is a chemotherapy drug, and linking it with Herceptin (also known as trastuzumab, which recognizes the HER2 protein on HER2+ cancer cells) enables the combination drug to find and kill HER2+ cancer cells. As well as being effective in women with high HER2 levels in their tumor, trastuzumab duocarmazine was also active in a subset of women with lower levels of the HER2 protein (even as low as IHC 1+/2+, ISH-). Women with HER2+ MBC on the drug had a PFS of 7.6 months and those with lower HER2 levels had a PFS of 4.9 months, showing that the drug extended life for patients who have run out of other treatment options. As of June 2019, there is an actively recruiting clinical trial (NCT03262935) in the US, Canada, and Europe for this drug. From: eurekalert.org/pub_releases...

[Rhwright12]

Thanks for the info! I’m on Perjeta/Herceptin now. So Kadcyla and these will be on the short list hopefully not for many years to come! But someday I’ll get to see these...😀

[kearnan]

I know you mean well but seriously someone would have to have a degree in biology or be a doctor to read and comprehend that. Anybody can basically pull anything off the internet these days to prove how they feel. For the average lay person (or just for me), its just a bunch of randomness. The author is a lay person. Just because one is diagnosed with cancer and deals with it does not make them experts. The very fact that it mentions this clinical testing was done in 115 patients makes it useless in my opinion. 115 people is not a valid clinical testing.