A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer (SERENA-2)
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ClinicalTrials.gov Identifier: NCT04214288 |
Recruitment Status :
Active, not recruiting
First Posted : January 2, 2020
Results First Posted : December 12, 2023
Last Update Posted : May 13, 2024
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | December 27, 2019 | ||||||||||||||
First Posted Date ICMJE | January 2, 2020 | ||||||||||||||
Results First Submitted Date ICMJE | August 23, 2023 | ||||||||||||||
Results First Posted Date ICMJE | December 12, 2023 | ||||||||||||||
Last Update Posted Date | May 13, 2024 | ||||||||||||||
Actual Study Start Date ICMJE | April 22, 2020 | ||||||||||||||
Actual Primary Completion Date | August 30, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Progression-free Survival (PFS) [ Time Frame: From date of randomisation to date of objective disease progression (or last evaluable assessment in the absence of progression) or death (up to data cut-off of 29 months) ] PFS was assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1. PFS was defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomised therapy or received another anti-cancer therapy prior to progression. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
Data from the 300mg arm should be interpreted with caution as recruitment to the 300mg arm was stopped early at 20 patients randomised and therefore the 300mg data is highly variable.
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Original Primary Outcome Measures ICMJE |
Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1 [ Time Frame: From date of randomisation to date of objective disease progression or death (up to approximately 3 years) ] Time from randomisation to objective disease progression (as assessed by RECIST) or death.
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Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
Number of Patients With Adverse Events [ Time Frame: From the date of first dose up to the safety follow-up period (28 days after last dose of AZD9833 and 56 days after last dose of fulvestrant) (up to data cut-off of 29 months) ] The safety and tolerability of AZD9833 when compared to fulvestrant in women with advanced ER-positive HER2-negative breast cancer was evaluated.
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Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer | ||||||||||||||
Official Title ICMJE | 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 | ||||||||||||||
Brief 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. | ||||||||||||||
Detailed Description | 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):
As of December 2020, the Sponsor stopped enrolment to Dose C. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced ER-Positive HER2-Negative Breast Cancer | ||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||
Actual Enrollment ICMJE |
240 | ||||||||||||||
Original Estimated Enrollment ICMJE |
288 | ||||||||||||||
Estimated Study Completion Date ICMJE | March 28, 2025 | ||||||||||||||
Actual Primary Completion Date | August 30, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Washout from prior tamoxifen: 4 months to elapse from last tamoxifen dose to pre-dose on-study biopsy. Exclusion Criteria: Intervention with any of the following:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 130 Years (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | Belgium, Canada, France, Georgia, Germany, Hungary, Israel, Italy, Korea, Republic of, Poland, Portugal, Russian Federation, Spain, Ukraine, United Kingdom, United States | ||||||||||||||
Removed Location Countries | Mexico | ||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04214288 | ||||||||||||||
Other Study ID Numbers ICMJE | D8530C00002 2019-003706-27 ( EudraCT Number ) |
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Has Data Monitoring Committee | Not Provided | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | AstraZeneca | ||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||
Current Study Sponsor ICMJE | AstraZeneca | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||
Investigators ICMJE | Not Provided | ||||||||||||||
PRS Account | AstraZeneca | ||||||||||||||
Verification Date | April 2024 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |