At a glance
ClinicalIndex Comparison RecordPhase 3Recruiting· 374 target
Drug / intervention
SPH4336 Tablets 400mg +1 moredrug
Likely dose
SPH4336 Tablets 400mgfrom record
Key inclusion· 6
- ✓Female, aged 18-75 years
- ✓ECOG performance status 0 or 1
- ✓Life expectancy at least 3 months
- ✓Locally advanced or metastatic breast cancer, hormone receptor positive and HER2 negative, unable to receive radical surgery/other local therapies
Key exclusion· 17
- ✕Prior treatment with CDK4/6 inhibitor
- ✕Inflammatory breast cancer
- ✕Unsuitable for endocrine therapy per investigator discretion
- ✕History of other malignancies within 5 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05744687Phase 3RecruitingMonitorUpdated 10mo ago · Completion was 1mo agoSlow Enrollment
Long Recruiting
Monitor
Randomized, Double-blind, Placebo-controlled, Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
In Brief
A Phase 3 clinical trial evaluating SPH4336 Tablets 400mg and SPH4336 Tablets Placebo for Locally Advanced or Metastatic Breast Cancer. Currently recruiting, targeting 374 participants across 9 sites.
Signals
Enrolling slower than its timeline implies
Detailed Summary
This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--
Timeline
Phase 3RecruitingOverdue
202420252026
First PostedFeb 2023
Enrollment StartApr 2023
Primary CompletionMay 2026
TodayJul 2026
First PostedFeb 27, 2023
Enrollment StartApr 24, 2023
Primary CompletionMay 31, 2026
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 3.3 years ago
Interventions
SPH4336 Tablets 400mgdrug
SPH4336 Tablets ：Orally, 400mg once a day; 28 days/cycle Letrozole tablets ：Orally, 2.5mg once a day; 28 days/cycle
SPH4336 Tablets Placebodrug
SPH4336 Tablets Placebo：Orally,28 days/cycle Letrozole tablets ：Orally, 2.5mg once a day; 28 days/cycle