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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR6390, Letrozole or Anastrozole | Experimental | SHR6390, Letrozole or Anastrozole |
|
| Placebo, Letrozole or Anastrozole | Placebo Comparator | Placebo, Letrozole or Anastrozole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR6390 Tablets | Drug | SHR6390 Tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| OS |
| Measure | Description | Time Frame |
|---|---|---|
| Ctrough | To explore the pharmacokinetic characteristics of SHR6390 population and the influencing factors | Up to 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nayima Bayaxi | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38470447 | Derived | Hong J, Chen T, Ouyang L, Du N, Li A, Zhou Z, Zhang H, Xia Z, Meng J. Cost-effectiveness comparison of dalpiciclib and abemaciclib combined with an aromatase inhibitor as first-line treatment for HR+/HER2- advanced breast cancer. Expert Rev Pharmacoecon Outcomes Res. 2024 Apr;24(4):559-566. doi: 10.1080/14737167.2024.2330542. Epub 2024 Mar 20. | |
| 37182538 |
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SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole
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| Placebo Tablets |
| Drug |
Placebo Tablets |
|
| Letrozole or Anastrozole Tablets | Drug | Letrozole or Anastrozole Tablets |
|
Overall Survival |
| up to 2 years |
| ORR | Objective Response Rate | Up to approximately 24 months |
| DoR | Duration of Objective Response | Up to approximately 24 months |
| CBR | Clinical Benefit rate | Up to approximately 24 months |
| 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 |
| Zhang P, Zhang Q, Tong Z, Sun T, Li W, Ouyang Q, Hu X, Cheng Y, Yan M, Pan Y, Teng Y, Yan X, Wang Y, Xie W, Zeng X, Wang X, Hu C, Geng C, Zhang H, Li W, Wu X, Zhong J, Xu J, Shi Y, Wei W, Bayaxi N, Zhu X, Xu B. Dalpiciclib plus letrozole or anastrozole versus placebo plus letrozole or anastrozole as first-line treatment in patients with hormone receptor-positive, HER2-negative advanced breast cancer (DAWNA-2): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2023 Jun;24(6):646-657. doi: 10.1016/S1470-2045(23)00172-9. Epub 2023 May 11. |
| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D000077384 | Anastrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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