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The study is being conducted to evaluate the efficacy and safety of HRS-8080 combined with dalpiciclib versus fulvestrant combined with dalpiciclib in patients with locally advanced/metastatic breast cancer who had developed drug resistance to prior adjuvant endocrine therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-8080 combined with Dalpiciclib | Experimental |
| |
| Fulvestrant combined with Dalpiciclib | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-8080 Tablet ; Dalpiciclib Isethionate | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator assessed Progression free survival (PFS) | PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death from any cause during the study. | Up to 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) evaluated by the blinded independent central review (BICR) | Up to 5 years | |
| Overall response rate (ORR) | Up to 5 years | |
| Clinical benefit rate (CBR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhan Zhang | Contact | +86 17721286165 | Zhan.zhang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital Fifth Medical Center | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| Fulvestrant injection ;Dalpiciclib Isethionate | Drug |
|
|
| Up to 5 years |
| Duration of response (DOR) | Up to 5 years |
| Overall survival (OS) | Up to 8 years |
| The incidence and severity of adverse events (AEs) | Up to 5 years |
| The incidence and severity of serious adverse events (SAEs) | Up to 5 years |
| Number of participants with vital sign abnormalities over the course of the study. Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure, and temperature | Up to 5 years |
| Number of participants with clinical laboratory test abnormalities for haematology and biochemistry parameters over the course of the study | Up to 5 years |
| Heart rate (beats per minute) measured by 12-lead electrocardiography. | Up to 5 years |
| QT interval (ms) measured by 12-lead electrocardiography. | Eastern Cooperative Oncology Group (ECOG) performance status. ECOG performance status was measured on a 6 point grade scale. 0: Fully active, able to carry on all pre-disease performance without restriction.
| Up to 5 years |
| Plasma concentrations of HRS-8080 and dalpiciclib isethionate | Up to approximately 2 years |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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