A Study of SHR6390 in Combination With Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

Hengrui Medicine

Status and phase: Unknown; Phase 3

Conditions: Advanced Breast Cancer

Treatments: Drug: Placebo; Drug: SHR6390; Drug: Fulvestrant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03927456

SHR6390-III-301

Details and patient eligibility

About

This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have received prior endocrine therapy are eligible for study.

Enrollment: 357 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
2. Age: 18 - 75 years old, postmenopausal women or prepostmenopausal women
3. Received prior endocrine therapy
4. One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy.
5. Eastern Cooperative Oncology Group [ECOG] 0-1

Exclusion criteria

1. Patients who received prior treatment with any CDK4/6 inhibitor, everolimus or fulvestant.
2. Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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357 participants in 2 patient groups, including a placebo group

SHR6390 + Fulvestrant

Experimental group

Description:

Intervention Drug: SHR6390, Fulvestrant

Treatment:

Drug: SHR6390

Drug: Fulvestrant

Placebo + Fulvestrant

Placebo Comparator group

Description:

Intervention Drug: Placebo, Fulvestrant

Treatment:

Drug: Fulvestrant

Drug: Placebo