Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women
Recruiting · NCT03201861 · Interventional (participants receive a specific treatment) · Lead sponsor: RenJi Hospital
View the official record on ClinicalTrials.gov →Interventions studied
EC to docetaxel or paclitaxelPaclitaxel, Cisplatin
What this trial is about
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 .
Who can take part
Age range
18 Years to 70 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Women aged ≥18 years and ≤70 years
- Have accepted surgical treatment, histologically confirmed early breast cancer, the pathological types of invasive carcinoma
- Not received treatment for breast cancer before operation
- 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
- HER2 negative: immunohistochemistry HER2 (1 +) or HER2 (0), or fluorescence in situ hybridization (FISH): not amplified
- Performance status (PS) 0-1
- 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
- No obvious main organs dysfunction
Exclusion criteria
- metastatic breast cancer
- Patient is pregnant or breast feeding
- Any evidence of sense or motor nerve disorders
- Bilateral Primary Breast Cancer (DCIS in one side not included)
- Patients with medical conditions taht indicate intolerant to adjuvant chemotherapy, including uncontrolled cardiovascular disease, severe infection
- Have received chemotherapy because of any malignancy other than breast cancer
- Known severe hypersensitivity to any drugs in this study
Where it is running
1 location listed.
- Renji Hospital, School of Medicine, Shanghai Jiaotong University - Shanghai, Shanghai Municipality, China