Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective， Randomized， Open-label， Multicentric，phaseIII Clinical Trial Compared With PC and CEF100 Followed by Docetaxel as Adjuvant Chemotherapy Regimen for Chinese Primary Triple Negative Breast Cancer Patients
Brief 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.


Options:
A: Inclusion Criteria:

* Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly)
* Histologically confirmed unilateral primary invasive carcinoma of the breast
* Clinical T1 - T4 (except inflammatory breast cancer)
* All clinical N (cN)
* No clinical evidence for distant metastasis (M0)
* Known HR status and HER2 status (local pathology) Tumor block available for central pathology review
* Performance Status ECOG ≤ 1 or KI ≥ 80%
* Negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients
* Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
* The patient must be accessible for treatment and follow-up

Additional Inclusion criteria for participation in the HR-/HER2+ sub-protocol:

* Confirmed ER and PR negative and HER2+ by central pathology
* Clinical cT1c - T4a-c (participation of patients with tumors \>cT2 is strongly recommended)
* All clinical N (participation of patients with cN0, if at least cT1c is strongly recommended)
* Patients must qualify for neoadjuvant treatment
* LVEF \> 50%; LVEF within normal limits of each institution measured by echocardiography and normal ECG (within 42 days prior to induction treatment)

Exclusion Criteria:

* Known hypersensitivity reaction to the compounds or incorporated substances
* Prior malignancy with a disease-free survival of \< 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri
* Non-operable breast cancer including inflammatory breast cancer
* Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor
* Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry
* Male breast cancer
* Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
* Breast feeding woman
* Sequential breast cancer
* Reasons indicating risk of poor compliance Patient not able to consent

Additional Exclusion Criteria for participation in the HER2+/HR- sub-protocol:

* Known polyneuropathy ≥ grade 2
* Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study
* Inadequate organ function (e.g. hepatic impairment, pulmonary disease, etc.)
* Uncompensated cardiac function (current unstable ventricular arrhythmia requiring treatment, history of symptomatic CHF NYHA classes II-IV), history of myocardial infarction or unstable angina pectoris within 6 months of enrollment, history of severe hypertension, CAD - coronary artery disease)
* Severe dyspnea
* Abnormal blood values:
* Thrombocytopenia \> CTCAE grade 1
* Increases in ALT/AST \> CTCAE grade 1
* Hypokalaemia \> CTCAE grade 1
* Neutropenia \> CTCAE grade 1
* Anaemia \> CTCAE grade 1
B: Inclusion Criteria:

* Triple-negative breast cancer
* Older than 18 years old
* Have tumor resection surgery
* Sufficient organ function (marrow, heart, liver)

Exclusion Criteria:

* Other malignancy
* Other serious disease( marrow, heart, liver)
C: Inclusion Criteria

* Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly)
* Histologically confirmed unilateral primary invasive carcinoma of the breast
* Clinical T1 - T4 (except inflammatory breast cancer)
* All clinical N (cN)
* No clinical evidence for distant metastasis (M0)
* Known HR status and HER2 status (local pathology)
* Tumor block available for central pathology review
* Performance Status ECOG \< 1 or KI \> 80 %
* Negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients
* Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
* The patient must be accessible for treatment and follow-up

Additional Inclusion Criteria for patients receiving chemotherapy:

* Laboratory requirements for patients receiving neoadjuvant chemotherapy (within 14 days prior to induction treatment):

  * Leucocytes \>= 3.5 10\^9/L
  * Platelets \>= 100 10\^9/L
  * Hemoglobin \>= 10 g/dL
  * Total bilirubin \<= 1 x ULN
  * ASAT (SGOT) and ALAT (SGPT) \<= 2.5 x UNL
  * Creatinine \<= 175 µmol/L (2 mg/dl)
* LVEF within normal limits of each institution measured by echocardiography and normal ECG (within 42 days prior to induction treatment)

Exclusion Criteria:

* Known hypersensitivity reaction to the compounds or incorporated substances
* Prior malignancy with a disease-free survival of \< 10 years, except curatively treated basalioma of the skin or pTis of the cervix uteri
* Non-operable breast cancer including inflammatory breast cancer
* Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor
* Concurrent treatment with other experimental drugs. Participation in another interventional clinical trial with or without any investigational not marketed drug within 30 days prior to study entry
* Male breast cancer
* Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
* Breast feeding woman
* Sequential breast cancer
* Reasons indicating risk of poor compliance
* Patients not able to consent

Additional Exclusion Criteria for patients receiving chemotherapy:

* Known polyneuropathy ≥ grade 2
* Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including acute cystitis and ischuria and chronic kidney disease
* Uncompensated cardiac function
* Inadequate organ function including:

  * Leucocytes \< 3.5 x 10\^9/l
  * Platelets \< 100 x 10\^9/l
  * Bilirubin above normal limits
  * Alkaline phosphatase \> 5 x UNL
  * ASAT and/or ALAT associated with AP \> 2.5 x UNL
D: 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.

Answer: D