Inflammatory Breast Cancer, Invasive Ductal Breast Cancer, Mucinous Breast Cancer, Tubular Breast Cancer
Conditions
Brief summary
The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer.
Detailed description
In this trial, all the patients will have weekly paclitaxel and cisplatin as neoadjuvant chemotherapy for 4 cycles. Patients with Her2 positive tumor will also receive the trastuzumab.
Interventions
DRUGPaclitaxel
DRUGCisplatin
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged ≥18years and ≤70 years 2. At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm, T2-4 N0-2M0 3. ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER/PR positive is defined as \>1% stained cells and HER2-positive is defined as immuno-histochemistry (IHC) 3+ or FISH ratio ≥ 2.0 4. No prior systemic or loco-regional treatment of breast cancer 5. ECOG 0-2 6. 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 （UNL）, creatinine≤1.5 UNL, bilirubin≤1.5UNL 7. No obvious main organs dysfunction
Exclusion criteria
1. Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug 2. Patient is pregnant or breast feeding 3. Inflammatory breast cancer and metastatic breast cancer 4. Any evidence of sense or motor nerve disorders 5. Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection 6. Any concurrent malignancy other than breast cancer 7. Know severe hypersensitivity to any drugs in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response of breast and lymph nodes | after 4 months preoperative treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and imaging response | 4 months during treatment | To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment |
| regional recurrence free survival (RRFS) | 5 years | RRFS is defined as the time period between registration and first event |
| Tolerability and Safety | 4 months during neoadjuvant therapy | Descriptive statistics for the treatment will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped |
| distant-disease- free survival (DDFS) | 5 years | DFS is defined as the time period between registration and first event |
| overall survival (OS) | 5 years | OS is defined as the time period between registration and first event |
| local recurrence free survival (LRFS) | 5 years | LRFS is defined as the time period between registration and first event |
Countries
China
Outcome results
None listed