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

Phase 3

• Conditions: Advanced Breast Cancer
• Interventions: Drug: SHR6390; Drug: Placebo; Drug: Fulvestrant

• Registration Number: NCT03927456
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-25
• Study Start: 2019-06-13
• Status Verified: 2020-06
• Last Update Submitted: 2021-05-31
• Last Update Posted: 2021-06-03
• Primary Completion: 2021-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 357

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR6390 + Fulvestrant	SHR6390	Intervention Drug: SHR6390, Fulvestrant
Placebo + Fulvestrant	Placebo	Intervention Drug: Placebo, Fulvestrant
SHR6390 + Fulvestrant	Fulvestrant	Intervention Drug: SHR6390, Fulvestrant
Placebo + Fulvestrant	Fulvestrant	Intervention Drug: Placebo, Fulvestrant

Primary Outcome Measures

Name	Time	Method
Investigator-assessed PFS	Up to approximately 24 months.	Investigator-assessed Progression Free Survival

Secondary Outcome Measures

Name	Time	Method
CBR	Up to approximately 24 months.	Clinical Benefit rate
DoR	Up to approximately 24 months	Duration of Objective Response
Progression-free Survival (PFS) per RECIST 1.1	Up to approximately 24 months.	PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.
OS	Up to approximately 2 years	Overall Survival
ORR	Up to approximately 24 months.	Objective Response Rate
Ctrough	Up to 4 weeks	Ctrough
AEs and SAEs	Up to approximately 24 months.	Number of Participants With adverse events (AEs) and serious adverse events (SAEs) Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.

Trial Locations

Locations (1)

Chinese Academy of Medical Science; 🇨🇳 Beijing, Beijing, China