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The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with intermediate or high risk early breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-8080 Group | Experimental | HRS-8080 tablets group. |
|
| Standard endocrine therapy Group | Active Comparator | Standard endocrine therapy: Letrozole tablets or Tamoxifen Citrate tablets or Anastrozole tablets or Exemestane tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-8080 Tablets | Drug | HRS-8080 tablets. |
| |
| Letrozole tablets |
| Measure | Description | Time Frame |
|---|---|---|
| The time from the date of randomization to the first occurrence of any of the following events: ipsilateral local or contralateral invasive recurrence, distant recurrence, or death from any cause. | Invasive Breast Cancer-Free Survival (IBCFS). | At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Invasive Disease-Free Survival (IDFS). | At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years. | |
| Distant Metastasis-Free Survival (DRFS). | At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yue He | Contact | +86-0518-82342973 | yue.he.yh58@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| Drug |
Letrozole tablets. |
|
| Tamoxifen Citrate Tablets | Drug | Tamoxifen Citrate tablets. |
|
| Anastrozole Tablets | Drug | Anastrozole tablets. |
|
| Exemestane tablets | Drug | Exemestane tablets. |
|
| Overall Survival (OS). | Survival follow-up every 3 months, up to 5 years. |
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| 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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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D013629 | Tamoxifen |
| D000077384 | Anastrozole |
| C056516 | exemestane |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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