Clinical Research Directory

Inclusion Criteria: * Written informed consent * Metastatic breast cancer fit to receive cytotoxic chemotherapy for metastatic disease * Measurable disease as per RECIST 1.1 * HER2 negative defined as ICH 0+, 1+ or 2+ and FISH/SISH/CISH(ration\<2.0) in the case of IHC 2+ * ECOG performance status 0 or 1 * ER+ve or ER-ve * Female age ≥18 years * Anticipated life expectancy \> 6 months * Haemoglobin \>10.0g/DL * Absolute neutrophil count\>1.5 x 10\^9/L * Platelet count\>100 x 10\^9/L * ALT/SGPT\<1.5 X ULN * Serum creatinine \<1.5 x ULN * Negative pregnancy test for all women of child bearing potential Exclusion Criteria: * Grade ≥2 oral mucositis or peripheral or sensory neuropathy * History of other malignancy * History of severe hypersensitivity ≥grade 3 to polysorbate 80- containing drugs and taxanes * Clinically significant cardiovascular disease * Any acute or chronic medical condition * Acute infection requiring systemic antibiotics or antifungal medication * Sex hormones * Administration of any live vaccine within 8 weeks * Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 * Participation in another clinical trial with an investigational drug within 30 days of randomisation * Pregnant or breast feeding women * Contraindications to the use of corticosteroid treatment * HER2 Positive breast cancer * Previous Paclitaxel chemotherapy in the adjuvant setting * Previous cytotoxic chemotherapy for metastatic disease * Palliative radiotherapy for metastatic disease within 4 weeks of randomisation * Symptomatic brain metastases confirmed with CT/MRI brain * History of other malignancy * Grade 2