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This study is a multicenter, open-label, randomized controlled Phase 3 clinical trial. It is planned to enroll 240 female patients with locally advanced or metastatic breast cancer followed by disease progression after previous endocrine therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-8080 Group | Experimental |
| |
| Fulvestrant Group | Active Comparator |
| |
| Exemestane in combination with Everolimus Group | Active Comparator |
| |
| Exemestane or Anastrozole or Letrozole Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-8080 Tablet | Drug | HRS-8080 tablet orally administered. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) evaluated by the blinded independent central review (BICR). | Approximately 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) evaluated by investigators. | Approximately 2 years. | |
| Overall response rate (ORR). | Approximately 2 years. | |
| Clinical benefit rate (CBR). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Li | Contact | +86-0518-82342973 | min.li.ml150@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| Fulvestrant injection |
| Drug |
Fulvestrant injection. |
|
| Exemestane tablets | Drug | Exemestane tablets orally administered. |
|
| Everolimus Tablets | Drug | Everolimus tablets orally administered. |
|
| Anastrozole Tablets | Drug | Anastrozole tablets orally administered. |
|
| Letrozole Tablets | Drug | Letrozole tablets orally administered. |
|
| Approximately 2 years. |
| Duration of response (DOR). | Approximately 2 years. |
| Overall survival (OS). | Approximately 3 years. |
| Adverse events (AEs). | Approximately 2 years. |
| Serious adverse events (SAEs). | Approximately 2 years. |
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410000 | 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 |
|---|---|
| D000077267 | Fulvestrant |
| C056516 | exemestane |
| D000068338 | Everolimus |
| D000077384 | Anastrozole |
| 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 |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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