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

Phase 3

• Conditions: Advanced Breast Cancer
• Interventions: Drug: Placebo Tablets; Drug: SHR6390 Tablets; Drug: Letrozole or Anastrozole Tablets

• Registration Number: NCT03966898
• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-29
• Study Start: 2019-07-19
• Status Verified: 2020-06
• Last Update Submitted: 2021-05-31
• Last Update Posted: 2021-06-02
• Primary Completion: 2022-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 426

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo, Letrozole or Anastrozole	Letrozole or Anastrozole Tablets	Placebo, Letrozole or Anastrozole
Placebo, Letrozole or Anastrozole	Placebo Tablets	Placebo, Letrozole or Anastrozole
SHR6390, Letrozole or Anastrozole	SHR6390 Tablets	SHR6390, Letrozole or Anastrozole
SHR6390, Letrozole or Anastrozole	Letrozole or Anastrozole Tablets	SHR6390, Letrozole or Anastrozole

Primary Outcome Measures

Name	Time	Method
Investigator-assessed PFS	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.	Investigator-assessed Progression Free Survival

Secondary Outcome Measures

Name	Time	Method
OS	up to 2 years	Overall Survival
DoR	Up to approximately 24 months	Duration of Objective Response
CBR	Up to approximately 24 months	Clinical Benefit rate
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.
ORR	Up to approximately 24 months	Objective Response Rate
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 v5.0	Up to approximately 24 months	Number of Participants With adverse events and serious adverse events Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0

Trial Locations

Locations (1)

Nayima Bayaxi; 🇨🇳 Shanghai, China