Triple Negative Breast Cancer Trial

Inclusion Criteria

• •Histologically confirmed ER-, PR-, primary breast cancer
• •Histologically confirmed HER2- primary breast cancer
• •Measurable confirmed metastatic or recurrent locally advanced disease unsuitable for local therapy but suitable for taxane chemotherapy
• •Patients with stable, treated bain metastases will be eligible providing informed consent can be given and that other sites of measurable disease are present.
• •Patients with bone metastases currently receiving bisphosphonates for palliation will be eligible providing informed consent can be given and that other sites of measurable disease are present
• •ECOG Performance Status 0, 1, or 2
• •Adequate haematology, biochemical indices (FBC, U \& Es)
• •LFTs = Normal bilirubin, AST and/or ALT = 3 x ULN if Alk Phos \>5 x ULN (or an isolated elevation AST/ALT of ≤5 x ULN
• •Adequate renal function - Creatinine clearance of \>25mls per minute
• •Written informed consent, able to comply with treatment and follow up
• •Previous exposure to a taxane in adjuvant chemotherapy within 12 months of trial entry
• •Previous treatment with a taxane for recurrent locally advanced disease
• •Previous treatment with a platinum chemotherapy drug
• •LFTs = Abnormal bilirubin (\> ULN), AST and/or ALT \>3 X ULN and Alk Phos \>5 x ULN (or an isolated elevation AST/ALT of \>5 x ULN)
• •Patients with a life expectancy of less than 3 months
• •Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous call carcinoma of the skin, unless there has been a disease free interval of at least 10 years
• •Previous or synchronous second breast cancer (unless also confirmed ER-, PR- and HER2-)
• •Patients with bone limited disease
• •Other serious uncontrolled medical conditions or concurrent medical illness likely to compromise life expectancy and/or the completion of trial therapy
• •Pregnant, lactating or potentially childbearing women not using adequate contraception