Trial · NCT06680921
A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)
NCT06680921, Phase 3, Active not recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE). Trials, record NCT06680921. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06680921
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)
- NCT number
- NCT06680921
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 482 participants, actual
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Conditions
- Locally Advanced or Metastatic Breast Cancer
- Interventions
- SIM0270, Everolimus (Afinitor®), Exemestane tablets, Fulvestrant injection
- First posted
- 2024-11-08
- Last updated
- 2026-08-11
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression free survival(PFS) , as assessed by blinded independent review committee(BIRC) according to RECIST1.1 | 2 year | PFS was defined as the time from the date of randomization to the first documented disease progression or death from any cause, whichever occurrs first. |
| Secondary | Progression free survival(PFS) , as assessed by investigator according to RECIST1.1 | 2 year | PFS was defined as the time from the date of randomization to the first documented disease progression or death from any cause, whichever occurrs first. |
| Secondary | Overall Survival (OS) | 3 year | OS is the time from the date of randomization to death from any cause. |
| Secondary | The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | 3 year | Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0 |
| Secondary | Blood concentrations | At five specified time points of the first 6 cycles (each cycle is 28 days) | Blood concentrations of SIM0270 and everolimus |
| Secondary | Objective Response Rate (ORR) by investigator | 2 year | The objective response rate is defined as the percentage of subjects with a complete response or partial response. |
| Secondary | Objective Response Rate (DOR) by investigator | 2 year | The DoR is defined as the time from the date of first complete or partial response until the date of documented progression or death from any cause. |
| Secondary | ORR by BIRC | 2 year | The objective response rate is defined as the percentage of subjects with a complete response or partial response. |
| Secondary | DOR by BIRC | 2 year | The DoR is defined as the time from the date of first complete or partial response until the date of documented progression or death from any cause. |
| Secondary | Clinical benefit rate(CBR) by investigator | 2 year | The clinical benefit rate is defined as the percentage of subjects with a complete response or partial response or stable disease for ≥24 weeks. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06680921
GET https://conductscience.org/api/trials/v1/NCT06680921/registered