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

Jiangsu HengRui Medicine Co., Ltd.426 enrolled

Overview

This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole in Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have not received systemic anticancer therapy are eligible for this study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

426

Conditions

Advanced Breast Cancer

Interventions

SHR6390 TabletsDRUG

SHR6390 Tablets

Placebo TabletsDRUG

Placebo Tablets

Letrozole or Anastrozole TabletsDRUG

Letrozole or Anastrozole Tablets

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 3. No prior systemic anti-cancer therapy for advanced HR+ disease. 4. Eastern Cooperative Oncology Group \[ECOG\] 0-1 Exclusion Criteria: 1. Patients who received prior treatment with any CDK4/6 inhibitor. 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.

Locations (1)

Nayima Bayaxi

Shanghai, China

Outcomes

Primary Outcomes

Investigator-assessed PFS

Investigator-assessed Progression Free Survival

Time frame: Every 8 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, Up to approximately 24 months.

Secondary Outcomes

Progression-free Survival (PFS) per RECIST 1.1

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.