Trial Number

978-19

Condition

Breast Cancer

Participant Age Range

18 years and older

Participant Gender

Female

Enrolling Participants

No

Overview

SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 versus Fulvestrant in Women with Advanced ER-Positive HER2-Negative Breast Cancer

The estrogen receptor (ER) alpha (ERa) is a well-established drug target in breast cancer with anti-hormonal endocrine therapies being the mainstay of treatment. The selective ER degrader (SERD) and antagonist fulvestrant is used as a standard-of-care treatment for ER-positive metastatic breast cancer. Although fulvestrant has demonstrated superior clinical efficacy to other endocrine therapies in this metastatic setting, it is not orally bioavailable and the monthly IM route of administration may limit its efficacy. AZD9833 is an orally bioavailable SERD which is being developed for the treatment of women with ER-positive breast cancer. AZD9833 has the potential to provide superior clinical benefit to existing endocrine therapies through enhanced bioavailability, target engagement and modulation in patients with ER-positive breast cancer. This open-label Phase 2 study will enroll post-menopausal women with advanced ER-positive HER2-negative breast cancer who are suitable for fulvestrant therapy. The study will evaluate the efficacy and safety of AZD9833 (75, 150 and 300 mg, PO) administered once daily as a monotherapy in comparison with fulvestrant administered according to its label. This study will be key to determining if AZD9833 should be further investigated in Phase 3 clinical trials.

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