To Evaluate a Phase Ia/Ib Clinical Study of EG017 in Patients With Advanced Breast Cancer.

Study Overview
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Brief Summary
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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.

Detailed Description
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The major aims of the study are to define the safety profile of this new drug, and to determine a recommended.

Official Title
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A Phase Ia/Ib Clinical Study 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.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: EG017


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, 18-75 years old; Expected survival ≥ 12 weeks; Subjects with ECOG score of physical state 0 1; Histologically confirmed recurrent or metastatic advanced breast cancer; Exclusion Criteria: Those who have had a severe allergic reaction to any drug or its components in this study in the past; Present with primary central nervous system (CNS) malignancies; Subjects with CNS metastasis who have failed local treatment (except asymptomatic BMS, or symptomatic BMS with complete remission of symptoms ≥ 2 weeks after treatment for BMS); Has any disease or syndrome that requires or is likely to require systemic steroid therapy during the study period; Gastrointestinal disorders or gastrointestinal diseases will significantly affect the absorption of test drugs (such as ulcerative disease, uncontrolled vomiting, diarrhea, malabsorption syndrome, biliary drainage status, etc.), or subjects cannot take drugs orally:

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EG017<br>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. | Drug: EG017<br>* According to the dosage group of the program, once a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |