OncoMatch/Clinical Trials/NCT06680921
A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)
Is NCT06680921 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including SIM0270 and Everolimus (Afinitor®) for locally advanced or metastatic breast cancer.
Treatment: SIM0270 · Everolimus (Afinitor®) · Exemestane tablets · Fulvestrant — This Phase III, randomized, open label, multicenter study will evaluate the efficacy and safety of SIM0270 combined with everolimus compared to physician's choice of treatment in subjects with ER+/HER2- locally advanced or metastatic breast cancer who have had previous treatment with CDK4/6 inhibitor.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
Required: ESR1 positive
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — locally advanced or metastatic
subjects had received 1 to 2 endocrine therapies in the locally advanced or metastatic setting with disease recurrence/disease progression while being treated with adjuvant endocrine therapy for ≥ 24 months and/or endocrine therapy in the locally advanced or metastatic setting, and derived a clinical benefit from therapy
Cannot have received: oral selective estrogen receptor degrader
Prior treatment with a oral selective estrogen receptor degrader (SERD)
Cannot have received: investigational ER-directed therapy
other investigational-ER-directed therapy
Cannot have received: PI3K-AKT-mTOR inhibitor
any PI3K-AKI-mTOR inhibitors
Lab requirements
Blood counts
Kidney function
Liver function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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