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Evaluating SIM0270 with Everolimus for Advanced Breast Cancer

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

Phase 3 Interventional Jiangsu Simcere Pharmaceutical Co., Ltd. · NCT06680921

This study is testing if a new treatment called SIM0270 combined with everolimus can help people with advanced breast cancer who have already tried other therapies and are seeing their cancer get worse.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment460 (estimated)
Ages18 Years and up
SexAll
SponsorJiangsu Simcere Pharmaceutical Co., Ltd. Industry-sponsored
Drugs / interventionschemotherapy
Locations60 sites (Bengbu, Anhui and 59 other locations)
Trial IDNCT06680921 on ClinicalTrials.gov

What this trial studies

This Phase III, randomized, open-label, multicenter study aims to assess the efficacy and safety of SIM0270 combined with everolimus compared to the physician's choice of treatment in patients with ER+/HER2- locally advanced or metastatic breast cancer. Participants must have previously received treatment with a CDK4/6 inhibitor and have measurable disease. The study will involve multiple treatment centers and will focus on patients who have experienced disease progression after prior therapies.

Who should consider this trial

Good fit: Ideal candidates are patients with ER+/HER2- locally advanced or metastatic breast cancer who have progressed after prior endocrine therapy.

Not a fit: Patients who have not received prior treatment with a CDK4/6 inhibitor or those with different breast cancer subtypes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced breast cancer.

How similar studies have performed: Other studies have shown promising results with similar combinations of targeted therapies in breast cancer, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

1. Subjects with histologically or cytologically confirmed ER+/HER2- locally advanced or metastatic breast cancer
2. Subjects must have at least one RECIST 1.1 measurable disease and /or at least 1 lytic or mixed (lytic + sclerotic) bone lesion
3. 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
4. Have disease that has demonstrated progression on or after prior treatment:

   1. 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
   2. subjects had received ≤ 1 chemotherapy in the locally advanced or metastatic setting.
5. Eastern Cooperative Oncology Group Performance Status 0-1
6. Adequate organ function

exclusion criteria:

1. Prior treatment with a oral selective estrogen receptor degrader (SERD) or other investigational-ER-directed therapy, or any PI3K-AKI-mTOR inhibitors
2. 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
3. Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
4. Active or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
5. Active cardiac disease or history of cardiac dysfunction, as defined in the protocol
6. Pregnant or breastfeeding

Where this trial is running

Bengbu, Anhui and 59 other locations

+10 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Locally Advanced or Metastatic Breast Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.