Mammary cancer
Conditions
Interventions
Experimental group:Darcilil combined with endocrine therapy
Sponsors
Hu'nan Provincial Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Postmenopausal or premenopausal/perimenopausal female patients >=18 years old shall meet the following requirements: (1) Previous bilateral oophorectomy, or aged >=60 years; (2) Aged = 1% of all tumor cells (reviewed and confirmed by investigators in the study center); (2) HER2 negative was defined as 0/1+ by standard IHC test; ISH was tested for HER2/CEP17 ratio less than 2.0 or HER2 gene copy number less than 4 (reviewed and confirmed by investigators at the study center); 3. The physical condition score of the Eastern Cancer Collaboration Group (ECOG) was 0-2; 4. Women of childbearing age must undergo a negative serum pregnancy test within 28 days prior to enrollment and be willing to use a medically approved highly effective contraceptive during the study period and within 1 year after the last study drug administration; 5. Patients who have received darcili-containing therapy before enrollment can also be included in this study if their baseline information, previous treatment and tumor efficacy evaluation information are complete; 6. With the patient's consent and signed informed consent, the patient is willing and able to follow the planned visit, research treatment plan, laboratory examination and other experimental procedures.
Exclusion criteria
Exclusion criteria: 1. Inability to swallow, intestinal obstruction, or other factors affecting drug administration and absorption; 2. Known allergy to tamoxifen, letrozole or anastrozole, LHRH agonists (goserrelin, leprerelin, etc.), darcyril or any excipients; 3. Known history of psychotropic substance abuse or drug use; 4. Lactating patients; 5. Patients who are participating in other studies; 6. Patients who have other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of study participation or interfere with the study results, and who are deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival as assessed by the investigator;overall survival;objective response rate;clinical benefit response; | — |
Countries
China
Contacts
Public ContactOuyang Quchang
Hu'nan Provincial Tumor Hospital
Outcome results
None listed