Inflammatory Breast Cancer Clinical Trial
— SHPD001Official title:
Phase 2 Study of Weekly Paclitaxel in Combination With Cisplatin as Neoadjuvant Therapy for Locally Advanced Breast Cancer Patients
Verified date | January 2017 |
Source | RenJi Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 132 |
Est. completion date | October 2016 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Fudan University Shanghai Cancer Center | Shanghai | Shanghai |
China | Shanghai Jiaotong University School of Medicine, Renji Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
RenJi Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathological complete response of breast and lymph nodes | after 4 months preoperative treatment | ||
Secondary | Tolerability and Safety | Descriptive statistics for the treatment will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped | 4 months during neoadjuvant therapy | |
Secondary | Clinical and imaging response | 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 | 4 months during treatment | |
Secondary | regional recurrence free survival (RRFS) | RRFS is defined as the time period between registration and first event | 5 years | |
Secondary | local recurrence free survival (LRFS) | LRFS is defined as the time period between registration and first event | 5 years | |
Secondary | distant-disease- free survival (DDFS) | DFS is defined as the time period between registration and first event | 5 years | |
Secondary | overall survival (OS) | OS is defined as the time period between registration and first event | 5 years |
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