Invasive Breast Cancer: HER-2 negative...Preferred regimens…Microtubule inhibitors…Vinorelbine...

...Women with:· Age > or =18 years; · Histologically confirmed adenocarcinoma of the breast;· Documented bone involvement +/- other non visceral metastatic disease previously untreated by chemotherapy;· Hormone receptor positive disease determined by ³10% positive stained cells for oestrogen and/or progesterone receptor by immunohistochemistry on the primary tumor or on metastatic site;· HER2 negative (assessed by 0-1+ IHC or 2+ IHC with FISH-) on the primary tumor or on metastatic site;· Complete staging within 4 weeks prior to registration;· Women of childbearing potential must be using a medically accepted method of contraception to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised;· Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment;· Patients who have received adjuvant or neoadjuvant chemotherapy are allowed if relapsing more than 6 months after the end of chemotherapy; · Patients should have received at least one hormone therapy for breast cancer in any given previous stage of the disease; · Patients must be under treatment by a bisphosphonate since at least one month before entering the study;· Patients may have received prior radiotherapy but a minimum of a 4 weeks interval must have elapsed;· Karnofsky Performance Status > or = 70%;· Life expectancy > or =16 weeks;· Adequate bone marrow, hepatic and renal functions as evidenced by the following:- Haemoglobin > or = 10 g/dL;- Absolute Neutrophil Count > or =1.5 x 109/L;- Platelet Count > or = 100 x 109/L;- Total Bilirubin 50 mL/min; calculated using the Cockroft and Gault formula.· Absence of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions should be assessed with the patient before registration in the trial;· The patient must have access to social insurance if applicable according to the local regulations.· The patient must give written (personally signed and dated) informed consent before completing any study-related procedure.`...

...c)Tumor cells from the primary tumor or from a biopsy of a metastatic site should be tested HER2 negative from the primary tumor or by biopsy of metastatic sites (measured with IHC 0-1+ or IHC 2+ with negative FISH, CISH). ...