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New treatment option for Locally Advanced or Metastatic Breast Cancer
Official title A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)
ClinicalTrials.gov ID: NCT06680921
What this study is testing
What is SIM0270?
SIM0270 is an investigational medicine, being studied as a potential treatment for locally advanced or metastatic breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people with histologically or cytologically confirmed ER+/HER2- locally advanced or metastatic breast cancer
- people 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...
- Have disease that has demonstrated progression on or after prior treatment:
- people had received 1 to 2 endocrine therapies in the locally advanced or metastatic setting with disease recurrence/disease progression while being...
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- people with histologically or cytologically confirmed ER+/HER2- locally advanced or metastatic breast cancer
- people 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...
- Have disease that has demonstrated progression on or after prior treatment:
- people 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...
- people had received ≤ 1 chemotherapy in the locally advanced or metastatic setting.
- Eastern Cooperative Oncology Group Performance Status 0-1
- Adequate organ function
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Hefei, Anhui, China
- Maanshan, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Quanzhou, Fujian, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Zhongshan, Guangdong, China
- Nanning, Guangxi, China
- Qinhuangdao, Hebei, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Anyang, Henan, China
- Luoyang, Henan, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Xiangyang, Hubei, China
- Changde, Hunan, China
+ 22 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Hefei, Anhui, China; Maanshan, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China and 36 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.