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To evaluate the safety, tolerability, pharmacokinetics and efficacy of EG017 in androgen receptor-positive, estrogen receptor-positive, and human epidermal growth factor receptor-2-negative patients with advanced breast cancer.
The major aims of the study are to define the safety profile of this new drug, and to determine a recommended.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EG017 | Experimental | 70 subjects: Part Ia 10 subjects: A total of 3 dose groups of 6 mg/day, 18 mg/day, 24 mg/day are planned. Once a day, each treatment cycle was administered for 28 days. Part Ib 60 subjects: A total of 2 dose groups of 18 mg/day, 24 or 12mg/day are planned. Once a day, each treatment cycle was administered for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EG017 | Drug | According to the dosage group of the program, once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of EG017 as Measured by the Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs). | The CTCAE criteria will be used to assess adverse events on this trial. | 28 Days |
| The effectiveness of EG017 in humans was evaluated by clinical benefit rate | The number and proportion of subjects in clinical remission at 24 weeks after administration were calculated | 24 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
postmenopausal women or women in a postmenopausal state
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Wang | Contact | +86 18201085833 | wangwei13@genscigroup.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of CAMS | Recruiting | Beijing | Benjing | 100020 | 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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| First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450000 | China |
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
| Wuhan Union Hospital | Recruiting | Wuhan | Hubei | 430000 | China |
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410000 | China |
| D017437 |
| Skin and Connective Tissue Diseases |