Invasive Ductal Breast Cancer, Tubular Breast Cancer, Mucinous Breast Cancer, Inflammatory Breast Cancer
Conditions
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.
Interventions
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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. Patients with locally advanced breast caner and had weekly paclitaxel and cisplatin as neoadjuvant chemotherapy. 3. Patients with pathological partial response or pathological complete response to neoadjuvant chemotherapy according to the Response Evaluation Criteria in Solid Tumors (RECIST). 4. Endocrine therapy and trastuzumab were allowed to use. 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. 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 |
|---|---|
| Disease-free survival (DFS) | Up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| local recurrence free survival (LRFS) | 5 years |
| distant-disease- free survival (DDFS) | 5 years |
Countries
China
Contacts
Primary ContactJinsong Lu, MD
Outcome results
None listed