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

Hengrui Medicine

Status and phase: Unknown; Phase 3

Conditions: Advanced Breast Cancer

Treatments: Drug: Letrozole or Anastrozole Tablets; Drug: SHR6390 Tablets; Drug: Placebo Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT03966898

SHR6390-III-302

Details and patient eligibility

About

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.

Enrollment: 426 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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426 participants in 2 patient groups, including a placebo group

SHR6390, Letrozole or Anastrozole

Experimental group

Description:

SHR6390, Letrozole or Anastrozole

Treatment:

Drug: SHR6390 Tablets

Drug: Letrozole or Anastrozole Tablets

Placebo, Letrozole or Anastrozole

Placebo Comparator group

Description:

Placebo, Letrozole or Anastrozole

Treatment:

Drug: Placebo Tablets

Drug: Letrozole or Anastrozole Tablets