CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 52 target
Drug / intervention
SPH4336 Tabletsdrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Locally advanced or metastatic breast cancer unable to receive radical surgery/local therapies
  • ✓At least one measurable lesion
  • ✓Life expectancy ≥3 months
  • ✓Voluntary informed consent
Key exclusion· 9
  • ✕Inflammatory breast cancer
  • ✕Prior malignancies
  • ✕Pregnant or lactating women
  • ✕Uncontrolled cardiac conditions or NYHA Class II or higher

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

Search/NCT05872347
NCT05872347Phase 2RecruitingOn Track
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A Phase II Study of SPH4336 in Combination With Endocrine Therapy in HR-positive, HER2-negative Breast Cancer Patients With Brain Metastases.

Shanghai Pharmaceuticals Holding Co., Ltd·interventional·Posted May 24, 2023·Updated May 5, 2026

In Brief

A Phase 2 clinical trial evaluating SPH4336 Tablets for Breast Cancer Brain Metastases. Currently recruiting, targeting 52 participants across 25 sites.

Detailed Summary

This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in breast cancer Patients with brain metastases.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer Brain Metastases
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
2024202520262027
First PostedMay 24, 2023
Enrollment StartSep 19, 2023
Primary CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 3.1 years agoPrimary completion in 6 months

Interventions

SPH4336 Tabletsdrug

SPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion; Exemestane：Administered by oral.