Hormone receptor-positive advanced breast cancer
Conditions
Interventions
Dalpiciclib treatment group:None
Sponsors
Harbin Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18 years, postmenopausal or premenopausal/menopausal transition period female or male patients. For female patients, the following condition must be met: (1) Have undergone bilateral oophorectomy in the past, or are aged = 60 years; (2) Age = 1% of all tumor cells with positive staining (as confirmed by investigators at the study center); 3. The physical status score of the Eastern Cancer Collaboration Group (ECOG) was 0-2 points; 4. Women of reproductive age must have a negative serum pregnancy test within 28 days prior to enrollment, and the male/female patient must be willing to use a medically approved highly effective contraceptive during the study period and within 1 year after the last administration of the study drug; 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 investigators opinion would significantly alter the benefitrisk 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 |
|---|---|
| Proportion of patients who were progression-free at multiple time intervals (e.g., 3, 6, 12, 18 mont; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate;Proportion of patients alive 1 and 2 years after starting dalpiciclib combination therapy;Events causing death;Objective response rate; | — |
Countries
China
Contacts
Public ContactCai Li
Harbin Medical University Affiliated Cancer Hospital
Outcome results
None listed