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Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women

RecruitingPhase 3Ages 18 Years - 70 YearsFemaleRenJi Hospital
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In plain words

What the trial is, and whether it could suit you

The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as adjuvant chemotherapy is more effective for high risk, HER2 negative breast cancer .

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Women aged ≥18 years and ≤70 years 2. Have accepted surgical treatment, histologically confirmed early breast cancer, the pathological types of invasive carcinoma 3. Not received treatment for breast cancer before operation 4. Triple-negative breast cancer confirmed by pathology, or pathology confirmed as the HR positive breast cancer at the same time meet the following conditions: axillary lymph node positive breast cancer, tumor size≥2 cm and Ki - 67 \>20% or tumor size ≥2 cm and grade III or tumor size ≥2cm and aged \<35 years 5. HER2 negative: immunohistochemistry HER2 (1 +) or HER2 (0), or fluorescence in situ hybridization (FISH): not amplified 6. Performance status (PS) 0-1 7. Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count(ANC)≥1.5×109/L, Platelets(PLT)≥100×109/L, Hemoglobin(Hb)≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit , creatinine≤1.5 upper normal limit, bilirubin≤1.5 upper normal limit 8. No obvious main organs dysfunction Exclusion Criteria: 1. metastatic breast cancer 2. Patient is pregnant or breast feeding 3. Any evidence of sense or motor nerve disorders 4. Bilateral Primary Breast Cancer (DCIS in one side not included) 5. Patients with medical conditions taht indicate intolerant to adjuvant chemotherapy, including uncontrolled cardiovascular disease, severe infection 6. Have received chemotherapy because of any malignancy other than breast cancer 7. Known severe hypersensitivity to any drugs in this study
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What it tests

  • Paclitaxel, Cisplatin
  • EC to docetaxel or paclitaxel
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Where

1 site
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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