Study to Compare the Effects of AZD9496 vs Fulvestrant in Breast Cancer.

Summary

This is an open label randomised multicentre pre-surgical pharmacodynamics study to compare and assess the biological effects of AZD9496 and fulvestrant in postmenopausal women with estrogen receptor (ER) positive (ER+), human epidermal growth factor receptor 2 (HER-2) negative (HER2-) primary breast cancer. Patients will receive AZD9496 or fulvestrant and will have an on-treatment image -guided core biopsy after 5-14 days of commencing treatment.

Timeline

Start

2017-10-05

Primary completion

2019-02-12

Completion

2019-02-12

Publications

• Robertson JFR, Evans A, Henschen S, Kirwan CC, Jahan A, Kenny LM, Dixon JM, Schmid P, Kothari A, Mohamed O, Fasching PA, Cheung KL, Wuerstlein R, Carroll D, Klinowska T, Lindemann JPO, MacDonald A, Mather R, Maudsley R, Moschetta M, Nikolaou M, Roudier MP, Sarvotham T, Schiavon G, Zhou D, Zhou L, Harbeck N. A Randomized, Open-label, Presurgical, Window-of-Opportunity Study Comparing the Pharmacodynamic Effects of the Novel Oral SERD AZD9496 with Fulvestrant in Patients with Newly Diagnosed ER+ HER2- Primary Breast Cancer. Clin Cancer Res. 2020 Aug 15;26(16):4242-4249. doi: 10.1158/1078-0432.CCR-19-3387. Epub 2020 Mar 31.

Drugs

Indications