Cisplatin added to chemotherapy for high-risk early stage breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.