RaSOLVE: 125I Radioactive Seed Marking Effects on Pathological Complete Response Rate and Prognosis Post-Neoadjuvant Therapy in Early/Advanced Breast Cancer

Korábbi kezelés

• Prior systemic chemotherapy, targeted therapy, immunotherapy, or radiotherapy within 1 year.
• Prior exposure to anthracyclines, taxanes, or platinum agents.
• Vaccination with live attenuated vaccine within 28 days.
• Major surgery within 28 days (except diagnostic procedures).
• Treatment with systemic immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks.

Más betegség

• Bilateral breast cancer or history of DCIS, LCIS, invasive breast cancer, or metastatic breast cancer.
• Any malignancy diagnosed within the past 5 years except cured cervical carcinoma in situ or non-melanoma skin cancer.
• Primary or secondary immunodeficiency; uncontrolled autoimmune disease (except controlled hypothyroidism or type 1 diabetes).
• Interstitial lung disease or severe chronic lung disease.
• Clinically significant cardiovascular disease, including:
  • NYHA class ≥ III
  • Myocardial infarction or stroke within 3 months
  • Uncontrolled hypertension
  • Clinically significant arrhythmia or heart failure
• Arterial/venous thrombosis within 3 months.
• Active HBV, HCV, or HIV infection.
• Severe infection within 4 weeks or systemic antibiotic-treated infection within 2 weeks.
• History of bone marrow or organ transplantation.
• Known allergy to study agents.
• Substance abuse or psychiatric conditions that may affect compliance.
• Any condition that, in the investigator's judgment, makes the patient unsuitable for the study.

Laborértékek

• Coagulation abnormalities (INR > 1.5 or APTT > 1.5×ULN).

Egyéb

• Peripheral neuropathy ≥ Grade 2.
• Participation in another clinical trial within 4 weeks.
• Pregnancy, breastfeeding, or planning pregnancy.

• Female patients aged 18 to 70 years.
• ECOG performance status 0-1.
• Pathologically confirmed, previously untreated, unilateral primary invasive breast cancer.
• Clinical stage cT1cN1-2M0 or cT2-3N0-2M0 (AJCC 8th edition).
• Adequate organ function within 7 days prior to randomization:
  • Hemoglobin ≥ 90 g/L
  • ANC ≥ 1.5×10⁹/L; Lymphocyte count ≥ 0.5×10⁹/L
  • Platelet count ≥ 100×10⁹/L
  • WBC 3.0-15×10⁹/L
  • ALT, AST ≤ 2.5×ULN; ALP ≤ 2.5×ULN; TBIL ≤ 1.5×ULN
  • Serum creatinine ≤ 1.5×ULN and creatinine clearance ≥ 60 mL/min
  • PT, APTT ≤ 1.5×ULN
  • Urine protein < 2+ or 24-hour urine protein ≤ 1 g
  • LVEF ≥ 55%
  • QTcF < 470 ms
• Negative serum pregnancy test within 3 days prior to first treatment for women of childbearing potential and agreement to use effective contraception.
• Willing and able to sign informed consent.