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This is a study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HRS-6209 combined with other treatment regimens in breast cancer patients, and preliminarily observe its anti-tumor efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-6209 in Combination with Letrozole Group | Experimental |
| |
| HRS-6209 combined with Letrozole and HRS-2189 Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-6209 Capsules | Drug | Oral HRS-6209 capsules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | 28 days after the first dose. | |
| Maximum tolerated dose (MTD) | 28 days after the first dose. | |
| Recommended phase II dose (RP2D) | 28 days after the first dose. | |
| Adverse events (AEs) | About 1 year. | |
| Serious adverse events (SAEs) | About 1 year. | |
| Objective response rate (ORR) | About 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Best overall response (BOR) | About 1 year. | |
| Duration of response (DoR) | About 1 year. | |
| Clinical benefit rate (CBR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyu Zhu | Contact | +86-0518-82342973 | Xiaoyu.zhu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| Letrozole Tablets | Drug | Oral Letrozole tablets. |
|
| HRS-2189 Tablets | Drug | HRS-2189 tablets. |
|
| About 1 year. |
| Progression-free survival (PFS) | About 1 year. |
| D017437 |
| Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |