AZD9833 plus Palbociclib in patients with ER+, HER2- with mBC (SERENA-4)

• Research type

  Research Study

• Full title

  SERENA-4: A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) plus Palbociclib versus Anastrozole plus Palbociclib for the Treatment of Patients with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

• IRAS ID

  1003455

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2020-002276-12

• Research summary

  Estrogen receptor alpha (ERα) is a well-established drug target in breast cancer with anti-hormonal endocrine therapies being the mainstay of treatment. The selective estrogen receptor degrader (SERD) and antagonist fulvestrant is considered as a standard of care treatment for ER-positive metastatic breast cancer. However the requirement for fulvestrant to be administered via a monthly intramuscular injection may limit its efficacy.
  AZD9833 is an oral potent SERD which has demonstrated anti-tumour activities in a wide range of pre-clinical cell lines and models. The first clinical data from a study of AZD9833 in breast cancer patients (SERENA-1) showed promising anticancer activity and that it was adequately tolerated. AZD9833 therefore has potential to provide superior clinical benefit to existing hormonal therapies in patients with hormone receptor-positive (ER-positive) breast cancer.
  The study intends to show the safety and efficacy of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) vs anastrozole (an aromatase inhibitor) and palbociclib in the treatment of patients with ER-positive advanced/metastatic breast cancer.
  Patients will be screened and randomised in a 1:1 ratio to study drug plus palbociclib or anastrazole plus palbociclib. They will then be followed up and assessed during regular 4-weekly treatment cycles until progression or other treatment discontinuation criteria are met. Subsequently, each patient will be followed every 12 weeks until death, withdrawal of consent or end of the study. The duration of the study for each patient is variable and depends on the response to study treatment. The study is planned to end in Jan 2029.
  The study is planned to take place in approx. 300 sites from 27 countries. Approx. 1680 patients with ER-positive, HER2 negative advanced stage breast cancer, who have not received any previous systemic treatment for advanced disease, will be screened in order to achieve approx.1342 patients randomised

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  21/SW/0003

• Date of REC Opinion

  22 Feb 2021

• REC opinion

  Further Information Favourable Opinion