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Trial Title:
To Evaluate a Phase Ia/Ib Clinical Study of EG017 in Patients With Advanced Breast Cancer.
NCT ID:
NCT05673694
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
EG017
Description:
According to the dosage group of the program, once a day.
Arm group label:
EG017
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.
Criteria for eligibility:
Criteria:
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:
Gender:
Female
Gender based:
Yes
Gender description:
postmenopausal women or women in a postmenopausal state
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital of CAMS
Address:
City:
Beijing
Zip:
100020
Country:
China
Status:
Recruiting
Contact:
Last name:
Binghe Xu, Doctor
Phone:
+86-10-87788826
Email:
xubinghe@medmail.com.cn
Facility:
Name:
First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Facility:
Name:
Wuhan Union Hospital
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Recruiting
Start date:
March 8, 2023
Completion date:
January 2, 2026
Lead sponsor:
Agency:
Changchun GeneScience Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Changchun GeneScience Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05673694
