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@article{Palmieri:2017:10.1007/s10549-017-4328-z,
author = {Palmieri, C and Stein, RC and Liu, X and Hudson, E and Nicholas, H and Sasano, H and Guestini, F and Holcombe, C and Barrett, S and Kenny, L and Reed, S and Lim, A and Hayward, L and Howell, S and Coombes, RC},
doi = {10.1007/s10549-017-4328-z},
journal = {Breast Cancer Research and Treatment},
pages = {343--353},
title = {IRIS study: a phase II study of the steroid sulfatase inhibitor Irosustat when added to an aromatase inhibitor in ER-positive breast cancer patients},
url = {http://dx.doi.org/10.1007/s10549-017-4328-z},
volume = {165},
year = {2017}
}

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TY  - JOUR
AB  - Purpose Irosustat is a first-generation, orally active, irreversiblesteroid sulfatase inhibitor. We performed a multicentre,open label phase II trial of the addition of Irosustatto a first-line aromatase inhibitor (AI) in patients withadvanced BC to evaluate the safety of the combination andto test the hypothesis that the addition of Irosustat to AImay further suppress estradiol levels and result in clinicalbenefit.Experimental design Postmenopausal women with ERpositivelocally advanced or metastatic breast cancer whohad derived clinical benefit from a first-line AI and whosubsequently progressed were enrolled. The first-line AIwas continued and Irosustat (40 mg orally daily) added.The primary endpoint was clinical benefit rate (CBR).Secondary endpoints included safety, tolerability, andpharmacodynamic end points.Results Twenty-seven women were recruited, four discontinuedtreatment without response assessment. Basedon local reporting, the CBR was 18.5% (95% CI6.3–38.1%) on an intent to treat basis, increasing to 21.7%(95% CI 7.4–43.7%) by per-protocol analysis. In thosepatients 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 was2.7 months (95% CI 2.5–4.6) in both the ITT and perprotocolanalyses. The most frequently reported grade 3/4toxicities were dry skin (28%), nausea (13%), fatigue(13%), diarrhoea (8%), headache (7%), anorexia (7%) andlethargy (7%).Conclusions The addition of Irosustat to aromatase inhibitortherapy resulted in clinical benefit with an acceptablesafety profile. The study met its pre-defined successcriterion by both local and central radiological assessments.
AU  - Palmieri,C
AU  - Stein,RC
AU  - Liu,X
AU  - Hudson,E
AU  - Nicholas,H
AU  - Sasano,H
AU  - Guestini,F
AU  - Holcombe,C
AU  - Barrett,S
AU  - Kenny,L
AU  - Reed,S
AU  - Lim,A
AU  - Hayward,L
AU  - Howell,S
AU  - Coombes,RC
DO  - 10.1007/s10549-017-4328-z
EP  - 353
PY  - 2017///
SN  - 0167-6806
SP  - 343
TI  - IRIS study: a phase II study of the steroid sulfatase inhibitor Irosustat when added to an aromatase inhibitor in ER-positive breast cancer patients
T2  - Breast Cancer Research and Treatment
UR  - http://dx.doi.org/10.1007/s10549-017-4328-z
UR  - http://hdl.handle.net/10044/1/53544
VL  - 165
ER  -

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