Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer

Prior treatment

• 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
• Contraindications to the use of corticosteroid treatment
• Previous Paclitaxel chemotherapy in the adjuvant setting
• Previous cytotoxic chemotherapy for metastatic disease

Other illness

• 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
• HER2 Positive breast cancer
• Palliative radiotherapy for metastatic disease within 4 weeks of randomisation
• History of other malignancy

Other

• Grade ≥2 oral mucositis or peripheral or sensory neuropathy
• Sex hormones
• Pregnant or breast feeding women
• Symptomatic brain metastases confirmed with CT/MRI brain
• Grade 2

• 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