Cisplatin added to chemotherapy for high-risk early stage breast cancer
Phase 3 Study of Weekly Paclitaxel in Combination With Cisplatin as Adjuvant Chemotherapy for Early Stage Human Epidermal Growth Factor Receptor-2 (HER2) Negative Breast Cancer in High-risk Women
This study is testing if adding cisplatin to standard chemotherapy can help women with high-risk early stage breast cancer do better than with just the usual treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 762 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT03201861 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of adding cisplatin to a standard chemotherapy regimen for women with high-risk, HER2 negative early stage breast cancer. Participants will be randomly assigned to receive either the cisplatin-based chemotherapy or the standard treatment. The study aims to determine if this combination improves outcomes compared to standard therapy alone. The focus is on women aged 18 to 70 who have specific pathological types of invasive breast cancer.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 70 with histologically confirmed early breast cancer and specific high-risk features.
Not a fit: Patients with HER2 positive breast cancer or those who have previously received treatment for breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for high-risk women with early stage breast cancer.
How similar studies have performed: Other studies have explored similar chemotherapy combinations, but the specific addition of cisplatin in this context is less common and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, Shanghai Municipality
- Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jinsong Lu, M.D. — Shanghai Jiao Tong University School of Medicine
- Study coordinator: Yueyao Du, M.D.
- Email: jessicayy8629@126.com
- Phone: 86-21-68385569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.