breast cancer
Conditions
Interventions
Experimental Group:Ribociclib (400 mg qd) + Investigator's choice of AI (letrozole 2.5 mg QD, anastrozole 1 mg QD, or exemestane 25 mg QD) + Goserelin (3.6 mg/28 days or 10.8 mg/12 weeks) or Leuprorel
Contral Group:4 cycles of epirubicin (90 mg/m^2, Q2W or Q3W) + cyclophosphamide (600 mg/m^2, Q2W or Q3W), followed by 12 weeks of paclitaxel (80 mg/m^2, QW), docetaxel (80 mg/m^2, Q3W), or nab-paclita
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent must be obtained before performing any study-specific procedures. 2. Female patients with breast cancer. 3. Age >=18 and =2 cm measured by breast MRI. Breast cancer stage II to III. No evidence of distant metastasis (M0). 6. ER-positive and/or PgR-positive and HER2-negative tumor assessed locally according to ASCO/CAP guidelines, with an ??ER expression >50%??. 7. Locally assessed Ki67 >=20%. 8. ECOG Performance Status of 0 or 1. 9. Adequate hematological, renal, and hepatic function as defined by the following criteria: Absolute Neutrophil Count (ANC) >=1.5 x 10^9/L Platelet count >=100 x 10^9/L Hemoglobin >=10 g/dL Alkaline Phosphatase (AP) =60 mL/min Potassium, total calcium, magnesium, sodium, and phosphorus within institutional normal limits, or correctable to within normal limits with supplements prior to the first dose of study medication. 10. Willing and able to comply with study visits, treatment, testing, and the study protocol.
Exclusion criteria
Exclusion criteria: 1. Prior treatment for the primary invasive breast cancer. 2. Metastatic (Stage IV) breast cancer. 3. Bilateral invasive breast cancer. 4. Multicentric breast cancer, defined as the presence of two or more separate tumor foci in different quadrants of the same breast. 5. Patients who have undergone a sentinel lymph node biopsy prior to the study treatment. 6. Pregnant or lactating women. 7. Impaired gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the study drug (e.g., uncontrolled ulcer disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). 8. Participation in another investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product (whichever is longer). 9. Patients with Child-Pugh class B or C. 10. Concurrent use of any other investigational drug or device. 11. Clinically significant, uncontrolled cardiac disease and/or cardiac repolarization abnormalities, including any of the following: History of myocardial infarction (MI), angina, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry. Documented cardiomyopathy. Left ventricular ejection fraction (LVEF) 160 mmHg or diastolic BP < 90 mmHg). 13. Inability to understand or comply with study instructions and requirements. 14. Known history of HIV infection (testing not mandatory).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preoperative endocrine prognostic index, PEPI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Response, pCR;Residual Cancer Burden, RCB;Event Free Survival, EFS;Complete cell cycle arrest, CCCA;Adverse Event, AE;ctDNA clearance; | — |
Countries
China
Contacts
Public ContactQiang Liu
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed