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

Launched by RENJI HOSPITAL · Jun 25, 2017

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a drug called cisplatin to a standard chemotherapy treatment can be more effective for women with early-stage, high-risk breast cancer. The focus is on women who have specific types of breast cancer that are HER2 negative, which means they don't have certain proteins that can make the cancer grow faster. The researchers believe that combining cisplatin with another drug called paclitaxel might help these patients have better outcomes.

To participate in this trial, you need to be a woman between 18 and 70 years old who has been diagnosed with early-stage breast cancer and has had surgery. Your cancer should be confirmed as either triple-negative or hormone receptor positive with certain characteristics, like having positive lymph nodes or a tumor size of at least 2 cm. Participants can expect to receive weekly treatments and will be closely monitored for their health throughout the study. It’s important to note that women who are pregnant, have other serious health issues, or have received previous chemotherapy for any cancer other than breast cancer are not eligible to join.

Gender

FEMALE

Eligibility 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