Phase
Condition
Breast Cancer
Treatment
N/AClinical Study ID
Ages 18-70 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Women aged from 18 to 70 years;
Histologically proven invasive unilateral breast cancer (regardless of the type);
Initial clinical condition compatible with complete initial resection;
No residual macro or microscopic tumor after surgical excision;
Beginning of chemotherapeutic treatment no later than day 42 after the initialsurgery;
positive lymph node or negative lymph node with tumor size > 1.0cm
Patient presenting one of the following criteria (reviewed before randomization byreferent 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].
No clinically or radiologically detectable metastases (M0);
No peripheral neuropathy > 1;
WHO Performance status (ECOG) of 0 or 1;
Adequate recovery from recent surgery (at least one week must have elapsed from thetime of a minor surgery (excluding breast biopsy); at least three weeks for majorsurgery);
Adequate hematological function (neutrophil count ³ 2x109/l, platelet count ³ 100x 109/l, Hemoglobin > 9 g/dl);
Adequate hepatic function: ASAT and ALAT ≤ 3 ULN alkaline phosphatases ≤ 2.5 ULN,totalbilirubin ≤ 1,5 ULN;
Adequate renal function: serum creatinine ≤ 1 ULN;
Patients accepting contraception intake during the overall length of treatment if ofchildbearing potential;
Adequate cardiac function, LEVF value > 50% by Muga scan or echocardiography;
Signed written informed consent.
Exclusion
Exclusion Criteria:
Bilateral breast cancer or patient with controlateral DCIS;
Any metastatic impairment, including homolateral sub-clavicular nodeinvolvement,regardless of its type;
Any T4 lesion (UICC1987) (cutaneous invasion, deep adherence, inflammatory breastcancer);
ER+ or PR+ or Her-2 overexpression
Any clinically or radiologically suspect and non-explored damage to the controlateralbreast;
Any chemotherapy, hormonal therapy or radiotherapy before surgery;
Previous cancer (excepted cutaneous baso-cellular epithelioma or uterin peripheralephitelioma) in the preceding 5 years, including invasive controlateral breast cancer;
Patients already included in another therapeutic trial involving an experimental drug;
Patients with other concurrent severe and/or uncontrolled medical disease or infectionwhich could compromise participation in the study;
LEVF < 50% (MUGA scan or echocardiography);
Clinically significant cardiovascular disease (e.g. unstable angina, congestive heartfailure, uncontrolled hypertension (>150/90), myocardial infarction or cerebralvascular accidents) within 6 months prior to randomization;
Known prior severe hypersensitivity reactions to agents containing Cremophor EL;
Women of childbearing potential who are unwilling or unable to use an acceptablemethod to avoid pregnancy for the entire study period and up to 8 weeks aftertreatment completion;
Women who are pregnant or breastfeeding. Adequate birth control measures should betaken during study treatment phase;
Women with a positive pregnancy test en enrollment or prior to study drugadministration;
Patients with any psychological, familial, sociological or geographical conditionpotentially hampering compliance with the study protocol and follow-up schedule; thoseconditions should be discussed with the patient before registration in the trial;
Individual deprived of liberty or placed under the authority of a tutor.