Breast Cancer Clinical Trial
Official title:
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.
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | January 2, 2026 |
Est. primary completion date | November 7, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | 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: |
Country | Name | City | State |
---|---|---|---|
China | Cancer Hospital of CAMS | Beijing | Benjing |
China | Hunan Cancer Hospital | Changsha | Hunan |
China | Wuhan Union Hospital | Wuhan | Hubei |
China | First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
China | Henan Cancer Hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Changchun GeneScience Pharmaceutical Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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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