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 (Jun 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
Treatments studied
Chemotherapy
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)
Demographics
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.
Frequently asked questions
Is NCT03201861 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages