Breast cancer
Conditions
Interventions
Experimental group:Foveciclib combined with an aromatase inhibitor, trastuzumab, and pertuzumab.
Foveciclib, 200 mg PO qd for 21 days, then 7 days off (28?day cycle)
Trastuzumab, 6 mg/kg, IV, once, 28?day cycle
Pertuzumab, 420 mg/kg, IV, once, 28?day cycle
Aromatase Inhibitor:
Letrozole 2.5 mg PO qd continuously (28?day cycle) or Anastrozole 1.0 mg PO qd continuously (28?day cycle).
Sponsors
Ningbo No.2 Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate in the clinical study; fully understand and are informed of the study details and sign the Informed Consent Form (ICF); are willing to comply with and capable of completing all trial procedures. 2. Aged >= 18 years, with tumor lesions suitable for receiving neoadjuvant therapy. 3. Early or locally advanced invasive breast cancer that is HR-positive (ER > 10%) and HER2-positive (IHC 3+ or IHC 2+/ISH+). 4. Pathologically assessed as stage II–IIIC (T2–3, N0–1, M0; or T2–3, N2–3, M0; or T4, any N, M0) according to the American Joint Committee on Cancer (AJCC) Staging Manual, 8th edition. 5. Any menopausal status. Postmenopausal status is defined as: a. after bilateral oophorectomy; b. age =60 years; c. age = 1.5 × 10?/L Hemoglobin >= 100 g/L (no red blood cell transfusion within 14 days prior to randomization) Platelet count >= 100 × 10?/L; Serum total bilirubin = 50 mL/min [calculation formula: Ccr = ((140 - age) × body weight (kg)) / (72 × serum creatinine (mg/dL)) or Ccr = ((140 - age) × body weight (kg)) / (0.818 × serum creatinine (µmol/L)); note: the result for female patients should be multiplied by 0.85]; Left ventricular ejection fraction (LVEF) >= 50% QT interval <= 480 ms.
Exclusion criteria
Exclusion criteria: 1.Currently receiving an investigational drug in a clinical trial or participating in any other medical research judged to be scientifically or medically incompatible with this study. 2.Has bilateral breast cancer, inflammatory breast cancer, or occult breast cancer. 3.Has a history of uncontrolled seizures or a history of central nervous system disease. 4.Has had other malignancies within the past 5 years. 5.Pregnant or breastfeeding women. 6.Subjects known to have severe hypersensitivity to any component of the study drug. 7.Severe comorbidities, such as uncontrolled hypertension (e.g., systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg; patients with well-controlled hypertension after antihypertensive therapy may be enrolled), diabetes mellitus, and active infection. 8.Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage or medical intervention (within 2 weeks prior to the first dose). 9.Myocardial infarction within 6 months prior to the first dose; poorly controlled arrhythmias (QTc interval = 470 ms, calculated using the Fridericia formula); or New York Heart Association (NYHA) Class III–IV cardiac insufficiency; or left ventricular ejection fraction (LVEF) < 50% on echocardiography; or pleural effusion, pericardial effusion, or ascites requiring clinical intervention. 10.Presence of dysphagia, active gastrointestinal disease, history of major gastrointestinal surgery, malabsorption syndrome, or other conditions that may affect the absorption of the study drug. 11.Patients with hepatitis B [hepatitis B surface antigen (HBsAg)-positive with detectable HBV-DNA indicating viral replication]; or patients with hepatitis C [hepatitis C virus (HCV) antibody-positive with detectable HCV-RNA indicating viral replication]; or positive syphilis screening (except those with positive specific antibody test but negative non-specific antibody test, and confirmed as having inactive infection based on clinical judgment); or known history of positive human immunodeficiency virus (HIV) or positive HIV screening. 12.Receipt of major surgery, radiotherapy, tumor immunotherapy, monoclonal antibody-based anti-tumor drug therapy, or other systemic anti-tumor treatments that the investigator considers may interfere with the efficacy of the study drug within 28 days prior to the first dose. 13.Patients who are planning to undergo or have previously undergone an organ or bone marrow transplant. 14.Subjects with a known history of psychotropic substance abuse or drug addiction. 15.Subjects who, in the opinion of the investigator, have any factors that make them unsuitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total pathologic complete response rate, tpCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;Safety;Dynamic changes in biomarker concentrations;breast pathologic complete response rate, bpCR; | — |
Countries
China
Contacts
Public ContactXujun Li
Ningbo No.2 Hospital
Outcome results
None listed