Breast Cancer
Conditions
Interventions
test group:Aromatase Inhibitor (AI): Letrozole (2.5 mg) / Anastrozole (1 mg) / Exemestane (25 mg), orally, once daily, continuously.
Dalpiciclib: 180 mg, orally, once daily, continuously (28 days per
Sponsors
Guangdong Provincial Hospital of Chines Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female, 18-70 years old; 2. Newly diagnosed, unilateral, invasive breast cancer; 3. AJCC 8th edition stage II-III (T2-4 or N1-3, M0); 4. HER2 positive: IHC 3+ or IHC 2+/FISH >= 2.0; 5. HR positive: ER and/or PR >= 1%; 6. ECOG 0-1; 7. Echocardiography LVEF >= 50%; 8. Organ function: (1) ANC >= 1.5 x 10^9/L; (2) PLT >= 100 x 10^9/L; (3) Hb >= 100 g/L; (4) ALT/AST <= 2.5 x ULN; (5) TBil <= 1.5 x ULN; (6) Cr <= 1.5 x ULN; 9. Voluntarily participates in this study, signs informed consent, has good compliance and is willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Prior anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, endocrine therapy, etc.). 2. Bilateral breast cancer, inflammatory breast cancer, or existing distant metastasis (M1). 3. History of other malignancies within the past 5 years (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix). 4. Pregnant or lactating women. 5. Severe cardiovascular or cerebrovascular diseases (e.g., uncontrolled hypertension, heart failure, history of myocardial infarction) or psychiatric disorders. 6. Any other conditions that, in the investigator's judgment, make the patient unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RCB Index and Classification; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Objective Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactXU RUI
Guangdong Provincial Hospital of Chines Medicine
Outcome results
None listed