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This study aims to evaluate the safety, tolerability, efficacy and pharmacokinetics of HRS-6208 in combination with HRS-8080 ± HRS-6209, or in combination with fulvestrant ± HRS-6209, or in combination with letrozole ± HRS-6209 in patients with advanced unresectable or metastatic breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: HRS-6208 + HRS-8080 ± HRS-6209 | Experimental | HRS-6208 + HRS-8080 ± HRS-6209. |
|
| Arm B: HRS-6208 + Fulvestrant ± HRS-6209 | Experimental | HRS-6208 + Fulvestrant ± HRS-6209. |
|
| Arm C: HRS-6208 + Letrozole ± HRS-6209 | Experimental | HRS-6208 + Letrozole ± HRS-6209. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-6208 Capsule | Drug | HRS-6208 capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | The DLT will be evaluated for the last participant in each dose group 28 days after the first dose. | |
| Recommended phase II dose (RP2D) | The evaluation of RP2D will be completed approximately one year later than DLT evaluation. | |
| Incidence and severity of adverse events (AEs) | Each individual participant will be followed for approximately 8 months, and the entire study process will last for approximately 36 months. | |
| Objective response rate (ORR) | For a single subject, the duration will be approximately 8 months, while the entire research process will last for 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months. | |
| Duration of response (DoR) | The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunxia Feng | Contact | +86-0518-82342973 | yunxia.feng.yf29@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | 116031 | China |
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An open label, multicenter, phase Ib/II study.
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| HRS-6209 Capsule | Drug | HRS-6209 capsule. |
|
| HRS-8080 Tablet | Drug | HRS-8080 tablet. |
|
| Fulvestrant injection | Drug | Fulvestrant injection. |
|
| Letrozole tablets | Drug | Letrozole tablets. |
|
| Progression-free survival (PFS) | The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months. |
| Overall survival (OS) | The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months. |
| The blood drug concentration of HRS-6208 | The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months. |
| The blood drug concentration of HRS-8080 | The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months. |
| The blood drug concentration of HRS-6209 | The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months. |
| The blood drug concentration of Letrozole | The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months. |
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610044 | China |
|
| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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