At a glance
ClinicalIndex Comparison Record- ✓Locally advanced or metastatic breast cancer unable to receive radical surgeries or other local therapies
- ✓At least one measurable lesion
- ✓ECOG performance status 0 or 1
- ✓Life expectancy at least 3 months
- ✕Inflammatory breast cancer
- ✕Unsuitable for endocrine therapy per investigator
- ✕Prior history of other malignancies
- ✕Known CNS metastases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II/III Study of SPH4336 in Combination With Endocrine Therapy in the Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer That Progressed on CDK4/6 Inhibitor Combined With Endocrine Therapy
In Brief
A Phase 3 clinical trial evaluating SPH4336 Tablets and SPH4336 Tablets Placebo for Locally Advanced or Metastatic Breast Cancer. Currently recruiting, targeting 254 participants across 22 sites.
Detailed Summary
This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on CDK4/6 inhibitor combined with endocrine therapy.
Study Details
Timeline
Interventions
SPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion
SPH4336 Tablets Placebo ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion