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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
According to the dosage group of the program, once a day.
Cancer Hospital of CAMS
Beijing, Benjing, China
RECRUITINGFirst Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGSafety 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.
Time frame: 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
Time frame: 24 Weeks
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Wuhan Union Hospital
Wuhan, Hubei, China
RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
RECRUITING