CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 300 target
Drug / intervention
XZP-3287+Fulvestrant +1 moredrug
Likely dose
XZP-3287+Fulvestrant 360 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05077449
NCT05077449Phase 3ActiveUpdate OverdueUpdated 25mo ago · Completion was 28mo ago
Enrollment Stalled

A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 in Combination With Fulvestrant Versus Placebo Combined With Fulvestrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer

Xuanzhu Biopharmaceutical Co., Ltd.·interventional·Posted Oct 14, 2021·Updated May 24, 2024

In Brief

A Phase 3 clinical trial evaluating XZP-3287+Fulvestrant and Placebo + Fulvestrant for Advanced Breast Cancer. Active but no longer recruiting, targeting 300 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

This is a phase III clinical trial to evaluate the efficacy and safety of XZP-3287 in combination with Fulvestrant versus placebo combined with Fulvestrant in Patients who have HR positive and Her2 negative recurrent/metastatic breast cancer and have received prior endocrine therapy are eligible for study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3Active
202220232024202520262027202820292030
First PostedOct 14, 2021
Enrollment StartNov 16, 2021
Primary CompletionFeb 22, 2024
Study CompletionNov 1, 2029
TodayJul 1, 2026
Enrollment to primary: 2.3 yearsPosted 4.7 years ago

Interventions

XZP-3287+Fulvestrantdrug

XZP-3287 360 mg orally Twice daily(Q12H) of every 28-day cycle Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle (28-day) until progressive disease

Placebo + Fulvestrantdrug

Placebo 360 mg orally Twice daily(Q12H) of every 28-day cycle Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle (28-day) until progressive disease