Trial of Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy
- Conditions
- Invasive Ductal Breast CancerTubular Breast CancerMucinous Breast CancerInflammatory Breast Cancer
- Interventions
- Registration Number
- NCT02879513
- Lead Sponsor
- RenJi Hospital
- Brief Summary
This trial will compare the administration of 2 cycles of paclitaxel and cisplatin (DP) versus 4 cycles of CEF as adjuvant chemotherapy for the patients with locally advanced breast cancer and who were pathological partial response to DP as neoadjuvant chemotherapy. Those who had pathological complete response to DP will be randomized to have 2 cycles of DP or have no further chemotherapy.
- Detailed Description
All the patients who had neoadjuvant chemotherapy and had pathological complete response (pCR) or partial response to DP will enrolled in this trial. Those who had pCR will randmized to have two cycles of DP as adjuvant chemotherapy or have no further chemotherapy. Those patients who had PR will be randomized to have two cycles of DP or four cycles of CEF. All the patients with hormonal receptor positive or Her2 overexpress tumors are allowed to accept endocrine therapy or anti-Her2 target therapy.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 290
- Women aged ≥18years and ≤70 years;
- Patients with locally advanced breast caner and had weekly paclitaxel and cisplatin as neoadjuvant chemotherapy.
- Patients with pathological partial response or pathological complete response to neoadjuvant chemotherapy according to the Response Evaluation Criteria in Solid Tumors (RECIST).
- Endocrine therapy and trastuzumab were allowed to use.
- 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.
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Switch to CEF Epirubicin Epirubicin 75 mg/m² IV push on day 1 every 3 weeks for 4 cycles. Cyclophosphamide 500 mg/m² IV push on day 1 every 3 weeks. 5-fluoruracil 500 mg/m² IV push on day 1 every 3 weeks. Switch to CEF Cyclophosphamide Epirubicin 75 mg/m² IV push on day 1 every 3 weeks for 4 cycles. Cyclophosphamide 500 mg/m² IV push on day 1 every 3 weeks. 5-fluoruracil 500 mg/m² IV push on day 1 every 3 weeks. Switch to CEF 5-fluoruracil Epirubicin 75 mg/m² IV push on day 1 every 3 weeks for 4 cycles. Cyclophosphamide 500 mg/m² IV push on day 1 every 3 weeks. 5-fluoruracil 500 mg/m² IV push on day 1 every 3 weeks. Pathological complete response group with chemotherapy 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. Continue the neoadjuvant regimen 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. Continue the neoadjuvant regimen Paclitaxel 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. Pathological complete response group with chemotherapy Paclitaxel 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.
- Primary Outcome Measures
Name Time Method Disease-free survival (DFS) Up to 5 years
- Secondary Outcome Measures
Name Time Method local recurrence free survival (LRFS) 5 years overall survival (OS) Up to 5 years Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 4 months during adjuvant therapy regional recurrence free survival (RRFS) 5 years distant-disease- free survival (DDFS) 5 years
Trial Locations
- Locations (1)
Shanghai Jiaotong University School of Medicine, Renji Hospital
🇨🇳Shanghai, Shanghai, China