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Clinical Trials in China / NCT03201861
Recruiting Phase 3

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

NCT03201861 · tracked via the Priya Life Science China tracker
Sponsor
RenJi Hospital
Phase
Phase 3
Started
2017-07-27
Last updated
2025-05-16

Condition(s) studied

Tubular Breast CancerMucinous Breast CancerInvasive Duct Carcinoma of Breast

Investigational drug(s) / intervention(s)

Paclitaxel, CisplatinEC to docetaxel or paclitaxel

Paclitaxel, Cisplatin: weekly paclitaxel and cisplatin

EC to docetaxel or paclitaxel: Standard adjuvant chemotherapy recommended by guideline

Study 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 .

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Renji Hospital, School of Medicine, Shanghai Jiaotong University Shanghai Shanghai Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03201861 on ClinicalTrials.gov ↗ ← All trials in China