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Recruiting NCT06680921

A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)

Phase III Interventional Locally Advanced or Metastatic Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SIM0270, Everolimus (Afinitor®), Exemestane tablets, Fulvestrant injection.
Who it may be relevant to
Registry conditions: Locally Advanced or Metastatic Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Open-label, Phase III Study of SIM0270 Combined With Everolimus Versus Treatment of Physician's Choice in Patients With CDK4/6 Inhibitors Previously Treated , ER+/HER2- Locally Advanced or Metastatic Breast Cancer

Overview

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.

Interventions

  • Drug SIM0270
    Experimental
  • Drug Everolimus (Afinitor®)
    Experimental and Active comparator
  • Drug Exemestane tablets
    Active Comparator
  • Drug Fulvestrant injection
    Active Comparator

Primary outcome measures

  • Progression free survival(PFS) , as assessed by blinded independent review committee(BIRC) according to RECIST1.1 [Time frame: 2 year]
Secondary outcome measures (12)
  • Progression free survival(PFS) , as assessed by investigator according to RECIST1.1 [Time frame: 2 year]
  • Overall Survival (OS) [Time frame: 3 year]
  • The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [Time frame: 3 year]
  • Blood concentrations [Time frame: At five specified time points of the first 6 cycles (each cycle is 28 days)]
  • Objective Response Rate (ORR) by investigator [Time frame: 2 year]
  • Objective Response Rate (DOR) by investigator [Time frame: 2 year]
  • ORR by BIRC [Time frame: 2 year]
  • DOR by BIRC [Time frame: 2 year]
  • Clinical benefit rate(CBR) by investigator [Time frame: 2 year]
  • CBR by BIRC [Time frame: 2 year]
  • Time To Progression (TTP) by investigator [Time frame: 2 year]
  • Time To Progression (TTP) by BIRC [Time frame: 2 year]

Eligibility criteria

Inclusion criteria

  • Subjects with histologically or cytologically confirmed ER+/HER2- locally advanced or metastatic breast cancer
  • Subjects must have at least one RECIST 1.1 measurable disease and /or at least 1 lytic or mixed (lytic + sclerotic) bone lesion
  • For women who are post menopausal must meet criteria as defined in the protocol.For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for screening period and the duration of study treatment
  • Have disease that has demonstrated progression on or after prior treatment:
  • 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
  • subjects had received ≤ 1 chemotherapy in the locally advanced or metastatic setting.
  • Eastern Cooperative Oncology Group Performance Status 0-1
  • Adequate organ function

Exclusion criteria

  • Prior treatment with a oral selective estrogen receptor degrader (SERD) or other investigational-ER-directed therapy, or any PI3K-AKI-mTOR inhibitors
  • Treatment with any investigational therapy within 28 days prior to study treatment.Treatment with moderate/strong CYP3A inhibitors or P-gP inhibitor within 14 days prior to first dose or moderate/strong CYP3A inducer within 28 days prior to first dose
  • Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
  • Active or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
  • Active cardiac disease or history of cardiac dysfunction, as defined in the protocol
  • Pregnant or breastfeeding

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 60 centers
  • The First Affiliated Hispital of Bengbu Medical University — Bengbu
  • Anhui Provincial Cancer Hospital — Hefei
  • The First Affiliated Hispital of Anhui Medical University — Hefei
  • Maanshan People's Hospital — Maanshan
  • Beijing Cancer Hospital — Beijing
  • The First Medical Center of PLA Ggeneral Hospital — Beijing
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing
  • The Second Affiliated Hospital of Chongqing Medical University — Chongqing
  • … and 52 more centers

Identifiers

NCT: NCT06680921 · SIM0270-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗