A Comparative Study of AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer

Official 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

Summary:

This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.

Trial Description

Primary Outcome:

  • Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumours (RECIST) version 1.1
Secondary Outcome:
  • Objective response rate (ORR) assessed by the Investigator as defined by RECIST version 1.1
  • Duration of response (DoR) assessed by the Investigator as defined by RECIST version 1.1
  • Percentage change in tumour size at 16 weeks
  • Overall survival (OS)
  • Clinical benefit rate at 24 weeks (CBR24)
  • Plasma concentrations of AZD9833 and, if appropriate, metabolite(s)
  • Percent change from baseline in ER and PgR expression and Ki67 labelling index.
  • Changes from baseline in Health Related Quality of Life (HRQoL)
Post-menopausal women with histologically or cytologically confirmed metastatic or loco-regionally recurrent ER-positive HER2-negative breast cancer before randomization and fulfilling all of the inclusion criteria and none of the exclusion criteria will be included. After the screening visit and confirmation of eligibility, patients will be randomly assigned in a 1:1:1:1 ratio to receive 1 of the following 4 treatments, consisting of 4-week treatment cycles until disease progression (assessed by the Investigator as defined by Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1):
  • AZD9833 (Dose A)
  • AZD9833 (Dose B)
  • AZD9833 (Dose C)
  • Fulvestrant (500 mg) During the treatment period, patients will have scheduled visits until treatment discontinuation. After the end of treatment, patients will attend 2 safety follow-up visits (at the time of treatment discontinuation and 28 days later) and will continue to be followed for survival. As of December 2020, the Sponsor stopped enrolment to Dose C.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society