Phase 2 Study of Weekly Paclitaxel in Combination With Cisplatin as Neoadjuvant Therapy for Locally Advanced Breast Cancer Patients
Overview
- Phase
- Phase 2
- Intervention
- Paclitaxel
- Conditions
- Tubular Breast Cancer
- Sponsor
- RenJi Hospital
- Enrollment
- 132
- Locations
- 2
- Primary Endpoint
- Pathological complete response of breast and lymph nodes
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Jinsong Lu
Director of Breast Surgery
RenJi Hospital
Eligibility Criteria
Inclusion Criteria
- •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
- •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 Criteria
- •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
Arms & Interventions
Paclitaxel and Cisplatin
Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles. Trastuzumab (only for human epidermal growth factor receptor-2(HER2)-positive patients): Loading dose: 4 mg/kg, Maintenance dose: 2 mg/kg, day 1 q day 8 for 16 weeks. Post-surgery: up to a total duration of 1 year
Intervention: Paclitaxel
Paclitaxel and Cisplatin
Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles. Trastuzumab (only for human epidermal growth factor receptor-2(HER2)-positive patients): Loading dose: 4 mg/kg, Maintenance dose: 2 mg/kg, day 1 q day 8 for 16 weeks. Post-surgery: up to a total duration of 1 year
Intervention: Cisplatin
Outcomes
Primary Outcomes
Pathological complete response of breast and lymph nodes
Time Frame: after 4 months preoperative treatment
Secondary Outcomes
- local recurrence free survival (LRFS)(5 years)
- regional recurrence free survival (RRFS)(5 years)
- overall survival (OS)(5 years)
- Tolerability and Safety(4 months during neoadjuvant therapy)
- Clinical and imaging response(4 months during treatment)
- distant-disease- free survival (DDFS)(5 years)