OncoMatch/Clinical Trials/NCT03201861
Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women
Is NCT03201861 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Paclitaxel, Cisplatin and EC to docetaxel or paclitaxel for tubular breast cancer.
Treatment: Paclitaxel, Cisplatin · EC to docetaxel or paclitaxel — 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 .
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (IHC 0 or 1+, or FISH not amplified)
HER2 negative: immunohistochemistry HER2 (1 +) or HER2 (0), or fluorescence in situ hybridization (FISH): not amplified
Allowed: ESR1 hormone receptor positive
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
Allowed: PR (PGR) hormone receptor positive
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
Disease stage
Excluded: Stage METASTATIC BREAST CANCER
early breast cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgery — breast cancer
Have accepted surgical treatment
Cannot have received: chemotherapy
Not received treatment for breast cancer before operation
Cannot have received: chemotherapy
Have received chemotherapy because of any malignancy other than breast cancer
Lab requirements
Blood counts
WBC ≥4.0×10^9/L, ANC ≥1.5×10^9/L, PLT ≥100×10^9/L, Hb ≥90g/L
Kidney function
creatinine ≤1.5 upper normal limit
Liver function
AST, ALT ≤1.5 upper normal limit, bilirubin ≤1.5 upper normal limit
Adequate bone marrow function: WBC≥4.0×109/L, ANC≥1.5×109/L, PLT≥100×109/L, Hb≥90g/L; AST, ALT≤1.5 upper normal limit, creatinine≤1.5 upper normal limit, bilirubin≤1.5 upper normal limit
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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