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 (Jun 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
Treatments studied
Endocrine / hormonal
Other
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.
Frequently asked questions
Is NCT06680921 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior oral selective estrogen receptor degrader, investigational ER-directed therapy, PI3K-AKT-mTOR inhibitor disqualifies patients from enrollment.
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.
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 qualifyRelated pages