Advanced Breast Cancer
Conditions
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.
Interventions
DRUGSHR6390 Tablets
SHR6390 Tablets
DRUGPlacebo Tablets
Placebo Tablets
DRUGLetrozole or Anastrozole Tablets
Letrozole or Anastrozole Tablets
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| DoR | Up to approximately 24 months | Duration of Objective Response |
| 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 |
| OS | up to 2 years | Overall Survival |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ctrough | Up to 4 weeks | To explore the pharmacokinetic characteristics of SHR6390 population and the influencing factors |
Countries
China
Outcome results
None listed