Breast cancer
Conditions
Interventions
Observation group:None
Sponsors
Jilin Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: To be eligible for admission to this trial, patients must meet all of the following enrollment criteria: 1. Age >=18 years old, postmenopausal or premenopausal/perimenopausal female or male patients, female patients must meet the following requirements: a) Previous bilateral oophorectomy, or age 60 years or older; b) Age = 1% of all tumor cells with positive staining (as confirmed by the investigator at the study center); 3. For special groups of breast cancer, one of the following needs to be met: a) Physical status score of Eastern Tumor Collaboration Group (ECOG) >=2 points; b) Elderly patients, aged >=65 years; c) Mild prolonged QT interval with QT interval =50%; e) Slightly poor bone marrow reserve function and: ANC>=1.5×10^9/L; or PLT>=75×10^9/L; or Hb>=90×10^9/L f) mild hepatic and renal insufficiency and: TBIL=50mL/min; (Cockcroft-Gault formula) 4. Have traceable medical history; 5. Non-pregnant or non-lactating female patients; 6. Not concurrently participating in other ongoing studies; 7. With the consent of the patient or legal representative and signed informed consent, the patient is willing and able to comply with planned visits, research treatment plans, laboratory tests and other experimental procedures.
Exclusion criteria
Exclusion criteria: 1. Any evidence of severe or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding disorders, active infections, including hepatitis B, C, and human immunodeficiency virus, or significant impairment of bone marrow reserves or organ function, including liver and kidney damage, which in the investigator's opinion would significantly alter the benefit/risk balance; 2. At the time of initiation of Darcilie therapy, the patient had not recovered from any CTCAE>=grade 3 toxicity due to previous treatment; 3. A known history of allergy to Darcyril or excipients or drugs with a chemical structure or class similar to Darcyril; 4. Patients deemed unsuitable for inclusion by the investigators;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival;Clinical benefit rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Security;Objective remission rate; | — |
Countries
China
Contacts
Public ContactFei Chen
Jilin Cancer Hospital
Outcome results
None listed