ArticleBreast cancer research and treatment2017
IRIS study: a phase II study of the steroid sulfatase inhibitor Irosustat when added to an aromatase inhibitor in ER-positive breast cancer patients.
Article in Breast cancer research and treatment, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 26 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
26 citing papers in PubMed.
- Assessing endocrine resistance: monitoring circulating ESR1 mutations in Irosustat-treated ER positive breast cancer.Breast cancer research and treatment · 2025Trial
- Targeted Therapies for Each Subtype of Breast Cancer.MedComm · 2026Review
- Arylsulfatase D promotes malignant phenotypes in glioblastoma cells and is linked to altered Hippo pathway phosphorylation.Frontiers in oncology · 2026Article
- Arylsulfamates inhibit colonic Bacteroidota growth through a sulfatase-independent mechanism.Proceedings of the National Academy of Sciences of the United States of America · 2025Article
- Estrogen sulfotransferase and sulfatase in steroid homeostasis, metabolic disease, and cancer.Steroids · 2024Review
- Targeting sex steroid biosynthesis for breast and prostate cancer therapy.Nature reviews. Cancer · 2023Review
- Antiproliferative activity and toxicity evaluation of 1,2,3-triazole and 4-methyl coumarin hybrids in the MCF7 breast cancer cell line.RSC medicinal chemistry · 2023Article
- Description of Chemical Synthesis, Nuclear Magnetic Resonance Characterization and Biological Activity of Estrane-Based Inhibitors/Activators of Steroidogenesis.Molecules (Basel, Switzerland) · 2023Review
- Targeting the formation of estrogens for treatment of hormone dependent diseases-current status.Frontiers in pharmacology · 2023Review
- Steroid Sulfation in Neurodegenerative Diseases.Frontiers in molecular biosciences · 2022Review
- New potent steroid sulphatase inhibitors based on 6-(1-phenyl-1Journal of enzyme inhibition and medicinal chemistry · 2021Article
- Steroid Sulphatase and Its Inhibitors: Past, Present, and Future.Molecules (Basel, Switzerland) · 2021Review
- Article
- Steroid hormones sulfatase inactivation extends lifespan and ameliorates age-related diseases.Nature communications · 2021Article
- Dysregulated androgen synthesis and anti-androgen resistance in advanced prostate cancer.American journal of clinical and experimental urology · 2021Review
- Recent progress in the development of steroid sulphatase inhibitors - examples of the novel and most promising compounds from the last decade.Journal of enzyme inhibition and medicinal chemistry · 2020Review
- Steroid Sulfatase Stimulates Intracrine Androgen Synthesis and is a Therapeutic Target for Advanced Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020Article
- Combination Therapy and Nanoparticulate Systems: Smart Approaches for the Effective Treatment of Breast Cancer.Pharmaceutics · 2020Review
- Identification of zebrafish steroid sulfatase and comparative analysis of the enzymatic properties with human steroid sulfatase.The Journal of steroid biochemistry and molecular biology · 2019Article
- Targeting stem cells in the realm of drug-resistant breast cancer.Breast cancer (Dove Medical Press) · 2019Review
Corrections and comments
- Erratum issued
Authors and funding
16 authors.
Funding
Abstract
purposeIrosustat is a first-generation, orally active, irreversible steroid sulfatase inhibitor. We performed a multicentre, open label phase II trial of the addition of Irosustat to a first-line aromatase inhibitor (AI) in patients with advanced BC to evaluate the safety of the combination and to test the hypothesis that the addition of Irosustat to AI may further suppress estradiol levels and result in clinical benefit. EXPERIMENTAL
designPostmenopausal women with ER-positive locally advanced or metastatic breast cancer who had derived clinical benefit from a first-line AI and who subsequently progressed were enrolled. The first-line AI was continued and Irosustat (40 mg orally daily) added. The primary endpoint was clinical benefit rate (CBR). Secondary endpoints included safety, tolerability, and pharmacodynamic end points.
resultsTwenty-seven women were recruited, four discontinued treatment without response assessment. Based on local reporting, the CBR was 18.5% (95% CI 6.3-38.1%) on an intent to treat basis, increasing to 21.7% (95% CI 7.4-43.7%) by per-protocol analysis. In those patients that achieved clinical benefit (n = 5), the median (interquartile range) duration was 9.4 months (8.1-11.3) months. The median progression-free survival time was 2.7 months (95% CI 2.5-4.6) in both the ITT and per-protocol analyses. The most frequently reported grade 3/4 toxicities were dry skin (28%), nausea (13%), fatigue (13%), diarrhoea (8%), headache (7%), anorexia (7%) and lethargy (7%).
conclusionsThe addition of Irosustat to aromatase inhibitor therapy resulted in clinical benefit with an acceptable safety profile. The study met its pre-defined success criterion by both local and central radiological assessments.
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