OncoMatch/Clinical Trials/NCT05744687
Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer
Is NCT05744687 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies SPH4336 Tablets 400mg for locally advanced or metastatic breast cancer.
Treatment: SPH4336 Tablets 400mg — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
Required: ESR1 positive
Required: PR (PGR) positive
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: cdk4/6 inhibitor
Lab requirements
Blood counts
Laboratory test results before randomization meet the relevant requirements for organ function
Kidney function
Laboratory test results before randomization meet the relevant requirements for organ function
Liver function
Laboratory test results before randomization meet the relevant requirements for organ function
Cardiac function
NYHA Class < II; QTcF < 470 ms; LVEF > 50%; no history of myocardial infarction, unstable angina, severe arrhythmia, or symptomatic congestive heart failure
Laboratory test results before randomization meet the relevant requirements for organ function. History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; NYHA( New York Heart Association) Class ≥II; QTcF≥ 470 ms; LVEF(Left Ventricular Ejection Fractions)≤ 50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05744687 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 positive is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR positive is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify