breast cancer
Conditions
Interventions
CohotA:Dalcilib: 100mg orally, every 28 days as a treatment cycle, with continuous medication for the first 3 weeks (day 1 to day 21) and rest (no medication) for the last 1 week (day 22 to day 28), f
CohotB:Dalcilib: 125mg orally, with a treatment cycle of 28 days, with continuous medication for the first 3 weeks (day 1 to day 21) and rest (no medication) for the last 1 week (day 22 to day 28), fo
Sponsors
Weihai Municipal Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria in order to qualify for this trial: 1. Female or male patients with breast cancer aged = 18 years, postmenopausal or premenopausal/perimenopausal; 2. Pathological examination confirmed that HR is positive (ER positive and/or PR positive) HER2 is negative or HER2 is low expression invasive breast cancer: ER positive and/or PR positive are defined as: the proportion of positively stained tumor cells to all tumor cells is = 10%; 3. Stage IIA-III patients: Phase IIA: N0 companion: Grade2 combined with high-risk factors: Ki-67 = 20%; 21 Gene RS score = 26 points Or high-risk genetic characteristics Grade3 N1 Phase IIB: N0 or N1 Phase III N0, N1, N2 or N3 4. Patients who are deemed necessary by researchers to receive CDK4/6i adjuvant therapy to reduce their risk of recurrence; 5. The Eastern Cancer Collaborative Group (ECOG) has a physical condition score of 0-2 points; 6. Non pregnant or non lactating female patients; 7. Not simultaneously participating in other ongoing research; 8. With the consent of the patient or their legal representative and having signed an informed consent form, they are willing and capable of following the planned visit, research treatment plan, laboratory tests, and other trial procedures.
Exclusion criteria
Exclusion criteria: If a patient meets any of the following conditions, they will not be allowed to enter this study: 1. Patients with untreated endocrine disorders in the past; 2. The clinical stage of the tumor is stage IV (metastatic) breast cancer; 3. Any evidence of severe or uncontrollable systemic diseases, including uncontrollable hypertension, active hemorrhagic diseases, active infections, including hepatitis B, hepatitis C, and human immunodeficiency virus, or severe damage to bone marrow reserves or organ function, including liver and kidney damage, or in the opinion of researchers, the use of this regimen by patients will greatly alter the balance of benefits/risks; 4. It is known that there is a history of allergies to darcilib or excipients, or drugs with similar chemical structures or categories to darcilib; 5. Patients deemed unsuitable for inclusion by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IDFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DMFS; | — |
Countries
China
Contacts
Public ContactQin chunxin
Weihai Municipal Hospital
Outcome results
None listed