Status:
COMPLETED
Addition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer
Lead Sponsor:
RenJi Hospital
Conditions:
Tubular Breast Cancer
Mucinous Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Women aged ≥18years and ≤70 years
- 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
- 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
- No prior systemic or loco-regional treatment of breast cancer
- ECOG 0-2
- 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
- No obvious main organs dysfunction
Exclusion
- Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug
- Patient is pregnant or breast feeding
- Inflammatory breast cancer and metastatic breast cancer
- Any evidence of sense or motor nerve disorders
- Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection
- Any concurrent malignancy other than breast cancer
- Know severe hypersensitivity to any drugs in this study
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT02199418
Start Date
January 1 2013
End Date
October 1 2016
Last Update
January 25 2017
Active Locations (2)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
2
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China, 200127