Adjuvant Platinum and Taxane in Triple-negative Breast Cancer (PATTERN)
Condition: Triple Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Previous studies in Western country show that triple-negative breast cancer has aggressive
      clinical and pathological features compared with non-triple negative breast cancer, including
      onset at a young age, advanced clinical stage, high histologic and nuclear grade and more
      distant recurrence.

      According to the characteristics of triple negative breast tumor, the TNBC patients can
      benefit neither from hormonal therapies nor from target therapies against Her2 receptors. The
      only systemic therapy currently available is chemotherapy, and prognosis remains poor. It
      becomes more and more important to investigate the sensitive chemotherapy regimen for triple
      negative patients.

      Cisplatin-based regimen was active for the patients of lung cancer, colorectal cancer and
      ect. Triple negative breast cancer patients were more sensitive to platinum-based
      chemotherapy regimens according to the results of some retrospective studies.

      The investigators hypothesized that paclitaxel combined with cisplatin is more sensitive to
      triple negative breast cancer compared with CEF followed by docetaxel.
    

Detailed description: 
      Eligibility Female adults(18-70 years old) are eligible if they had histologically confirmed
      primary breast cancer. Patients also had Eastern Cooperative Oncology Group(ECOG) Performance
      status of 0 or 1, absolute neutrophil count (ANC)>1500/mm3,hemoglobin >90g/dL, and platelet
      count >100,000/mm3,creatinine<2.5 times the upper limit of normal(ULN)）, transaminases<3
      times ULN or alkaline phosphatase<4 times ULN if transaminases was normal, and total
      bilirubin <1.5 times ULN. Exclusion criteria were active infection, pregnancy, other primary
      malignancy (except in situ carcinoma of cervix or adequately treated nonmelanomatous
      carcinoma of the skin), any documented distant metastasis and uncontrolled systemic diseases.

      This study protocol was approved by institutional ethic review boards and conducted according
      to guidelines for good clinical practice and the Helsinki Declaration.All patients provided
      written informed consent.

      Outcome Measures Primary Endpoint：5 year Disease Free Survival（DFS） Second Endpoints：5 year
      distant disease free survival （DDFS） 5 year event free survival （EFS） 5 year overall survival
      （OS） 5 year DFS in gBRCA1 mutation carriers and homologous recombination repair (HRR)-related
      gene mutation carriers
    

Intervention name(s): Paclitaxel Cisplatin; fluorouracil epirubicin cyclophosphamide and docetaxel (FEC-T)
Intervention type(s): Drug; Drug
Intervention description(s): Paclitaxel 80 mg/m2 D1，8，15 Cisplatin AUC=2 D1，8，15
1 cycle = 28days
PC*6; fluorouracil 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2 intravenously on day 1 every 21 days for three cycles followed by docetaxel 100 mg/m2 intravenously
Intervention MeSH terms: Paclitaxel; Docetaxel; Cyclophosphamide; Fluorouracil; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: triple negative breast cancer，local recurrence,distant metastasis