Breast cancer
Conditions
Interventions
Experimental group:dalpiciclib
Sponsors
Yunnan First People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Postmenopausal or premenopausal/perimenopausal women aged >=18 years; 2. Female invasive breast cancer patients diagnosed as HR+ by pathological examination; ER and/or PR positivity were defined as the percentage of positively stained tumor cells (confirmed by the investigator at the trial site) of at least 1% of all tumor cells. 3. Radical resection or breast-conserving surgery for breast cancer; 4. Postoperative pathology confirmed that >=4 positive axillary lymph nodes or 1-3 positive axillary lymph nodes and at least one of the following conditions: (1) Tumor >=5cm; (2) Histological grade III; (3) ki67>=20% detected by the center or other clinically recognized risk factors; 5. The Eastern Collaborative Oncology Group (ECOG) physical status score was 0-1; 6. Women of childbearing age must have a negative serum pregnancy test within 28 days before enrollment and be willing to use a medically approved highly effective contraceptive during the study and within 1 year after the last administration of the study drug; 7. Adequate organ and bone marrow function; 8. With the patient's consent and signed informed consent, the patient is willing and able to comply with the planned visit, study treatment plan, laboratory tests and other trial procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with inflammatory breast cancer; 2. Pregnant or lactating patients; 3. Patients who are enrolled in other studies; 4. Inability to swallow; 5. Patients deemed inappropriate for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Invasive disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival;Distant recurrence-free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactYang Kunxian
Outcome results
None listed