Tubular Breast Cancer, Mucinous Breast Cancer, Invasive Duct Carcinoma of Breast
Conditions
Brief 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 .
Detailed description
In this trial, patients will be randomly assigned in a 2:1 ratio to receive cisplatin-based adjuvant chemotherapy and to standard adjuvant chemotherapy.
Interventions
weekly paclitaxel and cisplatin
DRUGEC to docetaxel or paclitaxel
Standard adjuvant chemotherapy recommended by guideline
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Disease-Free Survival (DFS) Events | up to 5 year follow up | DFS is defined as the time period between registration and first event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Overall Survival (OS) Events | up to 5 year follow up | OS is defined as the time period between registration and first event |
| Number of participants with treatment-related adverse events as assessed by CTCAE v3.0. | 5 months during adjuvant therapy | Descriptive statistics for the treatment will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped |
Countries
China
Contacts
Primary ContactYueyao Du, M.D.
Backup ContactJie Zhang, M.D.
Outcome results
None listed