Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients
Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients
The investigators hypothesize that paclitaxel combined with cisplatin in a weekly-based
 regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast
 cancer.

 In patients with some sub-type advanced breast cancer, neo-adjuvant chemotherapy combined
 with endocrine therapy may improve the pathological remission rate.

 Premenopausal patients with triple negative breast caner and hormonal receptor positve breast
 cancer patients will be randominzed to have neoadjuvant chemotherapy combined with endocrine
 therapy or not.
In this trial, patients with ER and or PR positive breast cancer will be separately
 randomized to have chemotherapy or chemotherapy combined with endocrine therapy according to
 their menstrual status. Letrozole for the postmenopausal women and ovarian function
 suppression for the premenopausal women. Patients with triple negative breast cancer will be
 randomized to have neoadjuvant chemotherapy combined with ovarian function suppression if she
 is premenopausal. Postermenopausal patients with triple negative breast caner will only have
 neoadjuvant chemotherapy.

 Patients with Her2 overexpression can obtain anti-Her2 target therapy. This study has been
 amended to a 1:2 ratio to control and neoadjuvant chemotherapy combination of endocrine
 therapy.
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 N0-3M0;

 3. ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER and/or PR positive was
 defined as >1% stained cells.HER2-positive is defined as immuno-histochemistry (IHC)
 3+ or the ratio of HER2 gene signals to chromosome 17 signals >2.0 or HER2 gene copy
 >6.0.

 4. No prior systemic or loco-regional treatment of breast cancer;

 5. 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;

 6. 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.