4-hydroxytestosterone transdermal (CR 1477) / Curadis - LARVOL DELTA

Final Overall Survival Analysis of the Phase II SAKK 21/12 Trial of Transdermal CR1447 in Patients With Metastatic Breast Cancer. (PubMed, Clin Breast Cancer) - "In this final OS analysis, CR1447 was associated with an OS in line with other ET agents in patients with metastatic ER-positive, HER2-negative breast cancer who had received no more than 1 prior line of ET. Therapy was well tolerated with no treatment-related grade 3 to 5 toxicities."

Journal • P2 data • Breast Cancer • Dyslipidemia • Endocrine Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Hypertriglyceridemia • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2

Final Overall Survival (OS) analysis of the SAKK 21/12 trial. CR1447 in HR+/HER2- metastatic breast cancer and androgen receptor positive triple negative breast cancer. (SABCS 2023) - "Mutational analysis of AR/ER is ongoing to determine benefit of this treatment in specific subgroups. CR1447 might be a candidate drug to combine with other agents (CDK4/6 inhibitors or other targeted therapies)."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • AR • ER • HER-2

SAKK 21/12: CR1447 in Endocrine Responsive-HER2neg and TN-ARpos Breast Cancer (clinicaltrials.gov) - P2 | N=29 | Terminated | Sponsor: Swiss Group for Clinical Cancer Research | Trial completion date: Jun 2027 ➔ Oct 2022 | Active, not recruiting ➔ Terminated; The SAKK board decided to prematurely end the life-long follow-up of the trial SAKK 21/12, as 90% of the patients have died.

Metastases • Trial completion date • Trial termination • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Characterization of autochthonous lactobacilli from goat dairy products with probiotic potential for metabolic diseases. (PubMed, Heliyon) - "indicus CRL1447 as starter strain, supplemented with different probiotic consortia formed by Limosilactobacillus fermentum CRL1446, Lactiplantibacillus paraplantarum CRL1449, and CRL1472 strains...Hence, fermented goat milk incorporating novel probiotics represents a group of food products with broad prospects by their promising nutritive and therapeutic properties for metabolic diseases. The goat dairy product designed in this study could be used in the prevention of dyslipidemia and hyperglycemia in obese people."

Journal • Diabetes • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Obesity

SAKK 21/12: A stratified, multicenter phase II trial of transdermal CR1447 in endocrine responsive-HER2 negative and triple negative-androgen receptor positive metastatic or locally advanced breast cancer (ESMO-BC 2019) - P2; "CR1447 is an innovative endocrine therapy with a favorable safety profile. Despite not reaching the primary endpoint (DC24 in 30% of patients), the DC24-rate of 24% in the 2nd-line setting and one patient in prolonged PR are a signal of activity. Further evaluation in a truly endocrine sensitive population is warranted."

Clinical • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

CR1447 in Endocrine Responsive-HER2neg and TN-ARpos Breast Cancer (clinicaltrials.gov) - P2; N=90; Active, not recruiting; Sponsor: Swiss Group for Clinical Cancer Research; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

SAKK 21/12: A stratified, multicenter phase II trial of transdermal CR1447 in endocrine responsive-HER2 negative and triple negative-androgen receptor positive metastatic or locally advanced breast cancer. (PubMed, Ann Oncol) - No abstract available

Clinical • Journal • P2 data • AR • HER-2

Drug combination seeks to prevent endocrine resistance in breast cancer (Pharmacy Times) - "The combination of selinexor and 4-OHT may prevent endocrine resistance in patients with breast cancer by reprogramming tumor genes, according to a new study published in Cancers....Overall, the study found that the combination of selinexor and 4-OHT caused the tumors to regress faster and more completely than either drug alone, and this effect continued for several weeks following treatment. The study also showed that drug combination was more effective than either drug alone at reducing the tumor cells’ viability."

Clinical data

CR1447 in Endocrine Responsive-HER2neg and TN-ARpos Breast Cancer (clinicaltrials.gov) - P2; N=29; Active, not recruiting; Sponsor: Swiss Group for Clinical Cancer Research; Trial primary completion date: Dec 2018 ➔ Aug 2018

Clinical • Trial primary completion date