Adjuvant Platinum and Taxane in Triple-negative Breast Cancer (PATTERN)
Adjuvant Platinum and Taxane in Triple-negative Breast Cancer (PATTERN)
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.
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
Inclusion Criteria:

 1. Women aged from 18 to 70 years;

 2. Histologically proven invasive unilateral breast cancer (regardless of the type);

 3. Initial clinical condition compatible with complete initial resection;

 4. No residual macro or microscopic tumor after surgical excision;

 5. Beginning of chemotherapeutic treatment no later than day 42 after the initial
 surgery;

 6. positive lymph node or negative lymph node with tumor size > 1.0cm

 7. Patient presenting one of the following criteria (reviewed before randomization by
 referent pathologist):

 Triple negative （ER-PR-Her-2-） Hormone receptor negativity is defined as ER<1%, PR<1%
 (IHC), HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH negative].

 8. No clinically or radiologically detectable metastases (M0);

 9. No peripheral neuropathy > 1;

 10. WHO Performance status (ECOG) of 0 or 1;

 11. Adequate recovery from recent surgery (at least one week must have elapsed from the
 time of a minor surgery (excluding breast biopsy); at least three weeks for major
 surgery);

 12. Adequate hematological function (neutrophil count ³ 2x109/l, platelet count ³ 100x
 109/l, Hemoglobin > 9 g/dl);

 13. Adequate hepatic function: ASAT and ALAT ≤ 3 ULN alkaline phosphatases ≤ 2.5 ULN,total
 bilirubin ≤ 1,5 ULN;

 14. Adequate renal function: serum creatinine ≤ 1 ULN;

 15. Patients accepting contraception intake during the overall length of treatment if of
 childbearing potential;

 16. Adequate cardiac function, LEVF value > 50% by Muga scan or echocardiography;

 17. Signed written informed consent.

 Exclusion Criteria:

 1. Bilateral breast cancer or patient with controlateral DCIS;

 2. Any metastatic impairment, including homolateral sub-clavicular node
 involvement,regardless of its type;

 3. Any T4 lesion (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast
 cancer);

 4. ER+ or PR+ or Her-2 overexpression

 5. Any clinically or radiologically suspect and non-explored damage to the controlateral
 breast;

 6. Any chemotherapy, hormonal therapy or radiotherapy before surgery;

 7. Previous cancer (excepted cutaneous baso-cellular epithelioma or uterin peripheral
 ephitelioma) in the preceding 5 years, including invasive controlateral breast cancer;

 8. Patients already included in another therapeutic trial involving an experimental drug;

 9. Patients with other concurrent severe and/or uncontrolled medical disease or infection
 which could compromise participation in the study;

 10. LEVF < 50% (MUGA scan or echocardiography);

 11. Clinically significant cardiovascular disease (e.g. unstable angina, congestive heart
 failure, uncontrolled hypertension (>150/90), myocardial infarction or cerebral
 vascular accidents) within 6 months prior to randomization;

 12. Known prior severe hypersensitivity reactions to agents containing Cremophor EL;

 13. Women of childbearing potential who are unwilling or unable to use an acceptable
 method to avoid pregnancy for the entire study period and up to 8 weeks after
 treatment completion;

 14. Women who are pregnant or breastfeeding. Adequate birth control measures should be
 taken during study treatment phase;

 15. Women with a positive pregnancy test en enrollment or prior to study drug
 administration;

 16. Patients with any psychological, familial, sociological or geographical condition
 potentially hampering compliance with the study protocol and follow-up schedule; those
 conditions should be discussed with the patient before registration in the trial;

 17. Individual deprived of liberty or placed under the authority of a tutor.