SERENA-2
Research type
Research Study
Full title
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
IRAS ID
1003371
Contact name
Anne Armstrong
Contact email
Eudract number
2019-003706-27
Research summary
Breast cancer is the second most common cancer in the world and the most frequent
cancer in women. In Europe, it is estimated 522 513 women were diagnosed with breast
cancer in 2018 and 137 707 died from it.
The investigational study drug AZD9833 is a breast cancer drug that stops some of the
actions of oestrogen (female sex hormone) within the body which may have an effect on
the growth of certain types of breast cancer. The aim of the study is to see how safe and
effective AZD9833 is in treating advanced breast cancer, compared to fulvestrant which
is another breast cancer medication that works in the same way. The study also aim to
better understand breast cancer and associated health problems.
The study is open-label, meaning both the participants and researchers know which drug
is being given. The length of time participants will be in the study is not fixed and will
depend on how they respond to the study treatments. Participants will be randomly
assigned a study treatment and will receive 1 of the 4 treatments: AZD9833 (75 mg per
day), AZD9833 (150 mg per day), AZD9833 (300 mg per day) or Fulvestrant (500 mg
every 4 weeks, with an additional 500 mg dose given 2 weeks after the initial dose).
This study will involve approximately 288 women with advanced breast cancer across
multiple countries.
The sponsor of this study is AstraZeneca AB.REC name
London - Hampstead Research Ethics Committee
REC reference
20/LO/0944
Date of REC Opinion
3 Aug 2020
REC opinion
Further Information Favourable Opinion