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

Advanced Breast Cancer Clinical Trial

Official title:

A Phase III Study to Evaluate Efficacy and Safety of SHR6390 in Combination With Letrozole or Anastrozole Versus Placebo in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03966898
• Other study ID #: SHR6390-III-302
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 19, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 426
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• SHR6390 Tablets
SHR6390 Tablets
• Placebo Tablets
Placebo Tablets
• Letrozole or Anastrozole Tablets
Letrozole or Anastrozole Tablets

Locations

Country	Name	City	State
China	Nayima Bayaxi	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ctrough	To explore the pharmacokinetic characteristics of SHR6390 population and the influencing factors	Up to 4 weeks
Primary	Investigator-assessed PFS	Investigator-assessed Progression Free Survival	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	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.	Up to approximately 24 months
Secondary	OS	Overall Survival	up to 2 years
Secondary	ORR	Objective Response Rate	Up to approximately 24 months
Secondary	DoR	Duration of Objective Response	Up to approximately 24 months
Secondary	CBR	Clinical Benefit rate	Up to approximately 24 months
Secondary	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	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	Up to approximately 24 months