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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

426 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-19

Study Completion Date

2023-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SHR6390, Letrozole or Anastrozole

Group Type EXPERIMENTAL

SHR6390 Tablets

Intervention Type DRUG

SHR6390 Tablets

Letrozole or Anastrozole Tablets

Intervention Type DRUG

Letrozole or Anastrozole Tablets

Placebo, Letrozole or Anastrozole

Group Type PLACEBO_COMPARATOR

Placebo Tablets

Intervention Type DRUG

Placebo Tablets

Letrozole or Anastrozole Tablets

Intervention Type DRUG

Letrozole or Anastrozole Tablets

Interventions

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SHR6390 Tablets

Intervention Type DRUG

Placebo Tablets

Intervention Type DRUG

Letrozole or Anastrozole Tablets

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No