Breast cancer
Conditions
Interventions
A:Ribociclib + AI
B:Chemotherapy followed by physician's choice of endocrine therapy (AI +/- CDK4/6 inhibitors)
Sponsors
The Second Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
Female
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age: Female patients >=65 years of age; 2. Diagnosis: Histologically confirmed HR+/HER2- early invasive breast cancer; 3. Risk Profile: Node-positive, intermediate-to-high risk (according to UICC 8th Edition); 4. Performance Status: ECOG Performance Status of 0-2; 5. Prior Treatment: Completion of radical surgery within 8 weeks prior to randomization; 6. Organ Function: Adequate organ and bone marrow function; 7. Informed Consent: Ability to understand and willingness to sign the written Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: 1. Prior History: Previous history of invasive breast cancer; 2. Preoperative Treatment: Prior systemic antitumor therapy (e.g., neoadjuvant therapy) before surgery; 3. Prior CDK4/6 Exposure: Previous treatment with any CDK4/6 inhibitor; 4. Hypersensitivity: Known hypersensitivity or allergy to the study drugs or their excipients; 5. Metastasis: Presence of distant metastasis (Stage IV disease); 6. Comorbidities: Other active malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Invasive Disease-Free Survival, iDFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence-Free Survival, RFS;Distant Metastasis-Free Survival, DMFS;Overall Survival, OS;Safety;Quality of Life, QoL; | — |
Countries
China
Contacts
Public ContactMan Li
The Second Affiliated Hospital of Dalian Medical University
Outcome results
None listed