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

NCT06680921

Active Not RecruitingPhase 3

Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Conditions: Locally Advanced or Metastatic Breast Cancer

Interventions: SIM0270, Everolimus (Afinitor®), Exemestane tablets, Fulvestrant injection

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (57)

Bengbu, Anhui, China
Hefei, Anhui, China
Hefei, Anhui, China
Maanshan, Anhui, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Chongqing, Chongqing Municipality, China
Fuzhou, Fujian, China
Fuzhou, Fujian, China
Lanzhou, Gansu, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, 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
Zhengzhou, Henan, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Xiangyang, Hubei, China
Changde, Hunan, China
Changsha, Hunan, China
Changsha, Hunan, China
Yongzhou, Hunan, China
Nanjing, Jiangsu, China
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