Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk
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 .
| Condition(s) | Tubular Breast Cancer, Mucinous Breast Cancer, Invasive Duct Carcinoma of Breast |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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 participate | 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/ |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Lead sponsor | RenJi Hospital |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2017-07-27 |
| NCT ID | NCT03201861 |
| Official listing | https://clinicaltrials.gov/study/NCT03201861 |