Breast Cancer
Conditions
Brief summary
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
The major aims of the study are to define the safety profile of this new drug, and to determine a recommended.
Interventions
DRUGEG017
According to the dosage group of the program, once a day.
Sponsors
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Female, 18-75 years old; 2. Expected survival ≥ 12 weeks; 3. Subjects with ECOG score of physical state 0\ 1; 4. Histologically confirmed recurrent or metastatic advanced breast cancer;
Exclusion criteria
1. Those who have had a severe allergic reaction to any drug or its components in this study in the past; 2. 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); 3. Has any disease or syndrome that requires or is likely to require systemic steroid therapy during the study period; 4. 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:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 28 Days | The CTCAE criteria will be used to assess adverse events on this trial. |
| The effectiveness of EG017 in humans was evaluated by clinical benefit rate | 24 Weeks | The number and proportion of subjects in clinical remission at 24 weeks after administration were calculated |
Countries
China
Contacts
Primary ContactWei Wang
Outcome results
None listed