Efficacy and Safety Study of Neoadjuvant Chemotherapy for Local Advanced Triple Negative Breast Cancer Patients

This is an expanded access trial for Triple Negative Local Advanced Breast Cancer focused on measuring triple negative local advanced breast cancer(TNLABC),neoadjuvant chemotherapy Read More

Inclusion Criteria:

1. Women aged from 18 to 65 years;
2. Histologically or cytologically 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. 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<10%, PR<10% (IHC), HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH negative].

6. No clinically or radiologically detectable metastases (M0);
7. No peripheral neuropathy > 1;
8. WHO Performance status (ECOG) of 0 or 1;
9. Adequate hematological function (neutrophil count ³ 2x109/l, platelet count ³ 100x 109/l, Hemoglobin > 9 g/dl);
10. Adequate hepatic function: ASAT and ALAT £ 1.5 ULN alkaline phosphatases £ 2.5 ULN,total bilirubin £ 1,5 ULN;
11. Adequate renal function: serum creatinine £ 1.5 ULN;
12. Patients accepting contraception intake during the overall length of treatment if of childbearing potential;
13. Adequate cardiac function, LEVF value > 50% by Muga scan or echocardiography;
14. 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 tumor ³ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer);
4. Luminal A, Luminal B and Her-2 overexpression
5. Any clinically or radiologically suspect and non-explored damage to the controlateral breast;
6. Previous cancer (excepted cutaneous baso-cellular epithelioma or uterine peripheral epithelioma) in the preceding 5 years, including invasive controlateral breast cancer;
7. Patients already included in another therapeutic trial involving an experimental drug;
8. Patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study;
9. LEVF < 50% (MUGA scan or echocardiography);
10. 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;
11. Known prior severe hypersensitivity reactions to agents in this study
12. 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.